Zero-profile interbody spacer and coupled plate assembly

An implant for insertion into a disc space between vertebrae, wherein the implant includes a spacer portion, a plate portion coupled to the spacer portion, two bone fixation elements for engaging the vertebrae and a retention mechanism for preventing the bone fixation elements from postoperatively backing-out of the plate portion. The retention mechanism may be in the form of a spring biased snapper element that is biased into communication with the bone fixation elements so that once the bone fixation element advances past the snapper element, the snapper element is biased back to its initial position in which the snapper element interfaces with the bone fixation elements. Alternatively, the retention mechanism may be in the form of a propeller rotatable between a first position in which the bone fixation elements are insertable to a second position where the bone fixation elements are prevented from backing-out.

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Description
CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent Application No. 61/112,441, filed Nov. 7, 2008, entitled “Zero-Profile Interbody Spacer and Coupled Plate Assembly” and U.S. Provisional Patent Application No. 61/139,920, filed Dec. 22, 2008, entitled “Screw and Plate Locking Mechanisms for Smaller Bone Plates”, the contents of which are hereby incorporated by reference in their entirety.

BACKGROUND OF THE INVENTION

Intervertebral implants including interbody spacer portions and mechanically coupled plate portions are known in the art for restoring disc height, allowing fusion to occur between the adjacent vertebral bodies, and for providing stable fixation during healing.

It is desirable to construct a zero-profile implant wherein bone fixation elements that secure the implant to the vertebral bodies are blocked from backing-out of the bone and/or plate.

Additionally, it is desirable to construct a zero-profile implant that includes polyaxial bone fixation element couplings and features that prevent the implant from being implanted too deeply into a prepared disc space. Both screw back-out and over-insertion of the implant into a prepared disc space can have an adverse impact on the performance of the implant.

BRIEF SUMMARY OF THE INVENTION

The present invention relates generally to a spinal implant. More specifically, the present invention relates to a zero profile interbody spacer and coupled plate assembly for insertion into a disc space between adjacent superior and inferior vertebral bodies. The implant preferably includes a spacer portion, a plate portion coupled to the spacer portion, a plurality of bone fixation elements for engaging the vertebral bodies and a retention mechanism for preventing the bone fixation elements from postoperatively uncoupling from the implant.

In one exemplary embodiment, the implant includes first and second bone fixation elements, a spacer portion, a plate portion coupled to the spacer portion, and first and second spring-biased snapper elements for preventing the first and second bone fixation elements from backing-out of bone fixation holes formed in the plate portion (e.g., from postoperatively uncoupling from the implant). The spacer portion preferably includes a top surface for contacting the superior vertebral body, a bottom surface for contacting the inferior vertebral body, a first side surface, a second side surface, a leading surface and a trailing surface.

The plate portion includes a top surface, a bottom surface, a first side surface, a second side surface, a leading surface, a trailing surface, first and second bone fixation holes and first and second boreholes. The first and second bone fixation holes are sized and adapted for receiving the first and second bone fixation elements, respectively. The first bone fixation hole is angled so that the first bone fixation element engages the superior vertebral body while the second bone fixation hole is angled so that the second bone fixation element engages the inferior vertebral body. The first borehole is in communication with the first bone fixation hole and the second borehole is in communication with the second bone fixation hole.

The first and second spring-biased snapper elements are located in the first and second boreholes, respectively. The first and second spring biased snapper elements are moveable from a first position to a second position. In the first position, at least a portion of the first and second snapper elements protrude into the first and second bone fixation holes, respectively, so that once the first and second bone fixation elements have been inserted into the first and second bone fixation holes, respectively, the first and second snapper elements at least partially cover the first and second bone fixation elements, respectively, to prevent backing-out. The first and second spring biased snapper elements are preferably biased to the first position.

Preferably, insertion of the first and second bone fixation elements causes a head portion of the first and second bone fixation elements to contact the first and second spring biased snapper elements, respectively, to cause the first and second spring biased snapper elements to recoil from their first positions to the their second positions. Thereafter, further insertion of the first and second bone fixation elements causes the head portions of the first and second bone fixation elements to move distally of the first and second spring biased snapper elements resulting in the first and second snapper elements automatically moving from their second position to their first position.

The implant preferably further includes first and second stops to prevent over-insertion of the implant during implantation and to assist in securing a position of the implant during insertion of the first and second bone fixation elements. The first stop preferably extends superiorly of the top surface of the plate portion for contacting the superior vertebral body while the second stop extends inferiorly of the bottom surface of the plate portion for contacting the inferior vertebral body. The first and second stops are preferably integrally formed with the plate portion.

In another exemplary embodiment, the implant preferably includes first and second bone fixation elements, a spacer portion, a plate portion coupled to the spacer portion and a propeller element for preventing the first and second bone fixation elements from backing-out and over-insertion of the plate portion. The spacer portion includes a top surface for contacting the superior vertebral body, a bottom surface for contacting the inferior vertebral body, a first side surface, a second side surface, a leading surface and a trailing surface.

The plate portion includes a top surface, a bottom surface, a first side surface, a second side surface, a leading surface, a trailing surface, and first and second bone fixation holes. The first and second bone fixation holes are sized and adapted for receiving the first and second bone fixation elements, respectively. The first bone fixation hole is angled so that the first bone fixation element engages the superior vertebral body while the second bone fixation hole is angled so that the second bone fixation element engages the inferior vertebral body.

The propeller preferably includes a longitudinal axis extending between a first end and a second end. The propeller is coupled to the plate portion in-between the first and second bone fixation holes. In use, the propeller is rotatable between a first position wherein the propeller does not interfere with first and second bone fixation holes so that the first and second bone fixation elements can be inserted into the first and second bone fixation holes, respectively, to a second position wherein the first end of the propeller at least partially covers at least a portion of the first bone fixation hole and the second end of the propeller at least partially covers at least a portion of the second bone fixation hole to prevent backing-out of the first and second bone fixation elements once implanted. The propeller is preferably rotated through a range of about ninety degrees (90°) from the first position to the second position. The propeller preferably includes a threaded screw for engaging a threaded borehole formed in the plate portion. In use, in the first position, the longitudinal axis of the propeller is preferably oriented generally parallel to an axis of the implant and parallel to a cranial-caudal axis of the vertebral bodies so that the first end of the propeller extends superiorly of the top surface of the plate portion and the second end of the propeller extends inferiorly of the bottom surface of the plate portion so that the propeller acts as a stop during implantation of the implant to prevent over-insertion and to assist in securing a position of the implant during insertion of the first and second bone fixation elements.

In another exemplary embodiment, the implant sized and adapted for insertion into an intervertebral disc space between superior and inferior vertebral bodies includes: (a) first and second bone fixation elements; (b) a spacer portion including a top surface for contacting the superior vertebral body, a bottom surface for contacting the inferior vertebral body, a first side surface, a second side surface, a leading surface and a trailing surface; and (c) a plate portion coupled to the spacer portion. The plate portion including a top surface, a bottom surface, a first side surface, a second side surface, a leading surface and a trailing surface. The plate portion further including first and second bone fixation holes and first and second boreholes, the first and second bone fixation holes sized and adapted for receiving the first and second bone fixation elements, respectively. The first bone fixation hole is angled so that the first bone fixation element engages the superior vertebral body while the second bone fixation hole is angled so that the second bone fixation element engages the inferior vertebral body. The first borehole is in communication with the first bone fixation hole and the second borehole is in communication with the second bone fixation hole. The implant further including first and second spring-biased snapper elements for preventing the first and second bone fixation elements, respectively, from backing out. The first spring biased snapper element is located in the first borehole and the second spring biased snapper element is located in the second borehole. The first and second spring biased snapper elements are moveable from a first position to a second position, in the first position, at least a portion of the first and second snapper elements protrude into the first and second bone fixation holes, respectively, so that once the first and second bone fixation elements have been inserted into the first and second bone fixation holes, respectively, the first and second snapper elements at least partially cover the first and second bone fixation elements, respectively, to prevent backing-out, the first and second spring biased snapper elements being biased to the first position.

The height of the plate portion is preferably substantially equal to a height of the spacer portion and a width of the plate portion is preferably substantially equal to a width of the spacer portion. The spacer portion preferably includes first and second recesses formed in the first and second side surfaces thereof, respectively, and the plate portion preferably includes first and second projections extending from the plate portion for engaging the first and second recesses.

Each of the first and second spring biased snapper elements preferably includes a spring and a snapper element. The snapper element preferably including a tapered first end that protrudes into the first and second bone fixation holes for interacting with the first and second bone fixation elements, respectively, and a second end for interacting with the spring. The first and second spring biased snapper elements are preferably secured within the first and second boreholes, respectively, via first and second pins, respectively.

In use, insertion of the first and second bone fixation elements preferably causes the first and second spring biased snapper elements to move from their respective first position to their respective second positions. Insertion of the first and second bone fixation elements preferably causes a head portion of the first and second bone fixation elements to contact the first and second spring biased snapper elements, respectively, to cause the first and second spring biased snapper elements to recoil from their first positions to the their second positions. Further insertion of the first and second bone fixation elements preferably causes the head portions of the first and second bone fixation elements to move distally of the first and second spring biased snapper elements resulting in the first and second snapper elements automatically moving from their second position to their first positions.

The implant preferably also includes first and second stops to prevent over insertion of the implant during implantation and to assist in securing a position of the implant during insertion of the first and second bone fixation elements, the first stop extending superiorly of the top surface of the plate portion for contacting the superior vertebral body, the second stop extending inferiorly of the bottom surface of the plate portion for contacting the inferior vertebral body. The first and second stops are preferably integrally formed with the plate portion.

In another exemplary embodiment, the implant sized and adapted for insertion into an intervertebral disc space between superior and inferior vertebral bodies includes (a) first and second bone fixation elements; (b) a spacer portion including a top surface for contacting the superior vertebral body, a bottom surface for contacting the inferior vertebral body, a first side surface, a second side surface, a leading surface and a trailing surface; and (c) a plate portion coupled to the spacer portion. The plate portion includes a top surface, a bottom surface, a first side surface, a second side surface, a leading surface, a trailing surface, and first and second bone fixation holes. The first and second bone fixation holes sized and adapted for receiving the first and second bone fixation elements, respectively. The first bone fixation hole is angled so that the first bone fixation element engages the superior vertebral body and the second bone fixation hole is angled so that the second bone fixation element engages the inferior vertebral body. The implant further including (d) a propeller element having a longitudinal axis extending between a first end and a second end. The propeller element being coupled to the plate portion in-between the first and second bone fixation holes. The propeller being rotatable between a first position wherein the propeller does not interfere with first and second bone fixation holes so that the first and second bone fixation elements can be inserted into the first and second bone fixation holes, respectively, to a second position wherein the first end of the propeller at least partially covers at least a portion of the first bone fixation hole and the second end of the propeller at least partially covers at least a portion of the second bone fixation hole to prevent backing out of the first and second bone fixation elements once implanted. In the first position, the longitudinal axis of the propeller is preferably oriented generally parallel to an axis of the implant so that the first end of the propeller extends superiorly of the top surface of the plate portion and the second end of the propeller extends inferiorly of the bottom surface of the plate portion so that the propeller acts as a stop during implantation of the implant to prevent over insertion of the implant and to assist in securing a position of the implant during insertion of the first and second bone fixation elements.

The propeller is preferably rotated through a range of about ninety degrees (90°) from the first position to the second position. The propeller preferably includes a threaded screw for engaging a threaded borehole formed in the plate portion. The trailing surface of the plate portion preferably includes tapered recesses that form guide ramps for the first and second ends of the propeller as the propeller is being rotated from the first position to the second position and so that in the second position, the propeller lies flush with the trailing surface of the plate portion.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The foregoing summary, as well as the following detailed description of preferred embodiments of the application, will be better understood when read in conjunction with the appended drawings. For the purposes of illustrating the implant of the present application, there is shown in the drawings preferred embodiments. It should be understood, however, that the application is not limited to the precise arrangements and instrumentalities shown. In the drawings:

FIG. 1A illustrates an anterior perspective view of an implant according to a first preferred embodiment of the present application;

FIG. 1B illustrates a side elevational view of the implant of FIG. 1A;

FIG. 1C illustrates a top plan view of the implant of FIG. 1A;

FIG. 1D illustrates an anterior elevational view of the implant of FIG. 1A;

FIG. 1E illustrates a cross-sectional view of the implant of FIG. 1A, taken along line 1E-1E of FIG. 1C;

FIG. 1F illustrates a cross-sectional view of the implant of FIG. 1A, taken along line 1F-1F of FIG. 1A;

FIG. 2A illustrates an anterior perspective view of a plate portion of the implant of FIG. 1A;

FIG. 2B illustrates a cross-sectional view of the plate portion of FIG. 2A, taken along line 2B-2B of FIG. 2A;

FIG. 2C illustrates a magnified, cross-sectional view of a retention mechanism used in connection with the implant of FIG. 1A;

FIG. 2D illustrates a perspective view of the retention mechanism of FIG. 2C;

FIGS. 2E-2J illustrate various alternate views of the implant shown in FIG. 1A incorporating various alternate designs of a stop member configured for embedding at least partially into the vertebral bodies during impaction;

FIG. 3A illustrates a top plan view of an exemplary removal instrument for contacting and recoiling the retention mechanism of FIG. 2D to enable removal of the bone fixation elements from the implant;

FIG. 3B illustrates a magnified, cross-sectional view of the removal instrument of FIG. 3A, taken along line 3B-3B of FIG. 3A;

FIG. 4A illustrates an anterior perspective view of an implant according to a second preferred embodiment of the present application, the retention mechanism being in a first position;

FIG. 4B illustrates a side elevational view of the implant shown in FIG. 4A, the retention mechanism being in the first position;

FIG. 4C illustrates an anterior perspective view of the implant shown in FIG. 4A, the retention mechanism being in a second position;

FIG. 4D illustrates a side elevational view of the implant shown in FIG. 4A, the retention mechanism being in the second position;

FIG. 5A illustrates an anterior perspective view of the implant shown in FIG. 4A inserted into an intervertebral disc space between adjacent vertebral bodies, the retention mechanism being in the first position wherein the retention mechanism acts as a stop preventing over-insertion of the implant into the disc space;

FIG. 5B illustrates an anterior perspective view of the implant shown in FIG. 4A inserted into an intervertebral disc space between adjacent vertebral bodies, the retention mechanism being in the second position;

FIG. 6A illustrates a top perspective view of the implant shown in FIG. 4A, the plate portion incorporating an optional thread blocking mechanism;

FIG. 6B illustrates an alternate top perspective view of the implant shown in FIG. 6A illustrating the optional thread blocking mechanism in contact with an implanted bone fixation element;

FIG. 7A illustrates an anterior exploded perspective view of the plate portion used in connection with the implant of FIG. 4A, the retention mechanism incorporating a second exemplary coupling mechanism for engaging the plate portion;

FIG. 7B illustrates a cross-section view of the plate portion and retention mechanism shown in FIG. 7A, taken along line 7B-7B of FIG. 7A;

FIG. 8 illustrates a partial cross-sectional view of a plate portion used in connection with the implant of FIG. 4A, the retention mechanism incorporating a third exemplary coupling mechanism for engaging the plate portion;

FIG. 9A illustrates an anterior perspective view of the implant shown in FIG. 4A, the implant incorporating a second exemplary spacer portion;

FIG. 9B illustrates a top perspective view of the implant shown in FIG. 9A with an optional porous PEEK portion omitted;

FIG. 9C illustrates a cross-sectional view of the implant shown in FIG. 9A, taken along line 9C-9C in FIG. 9A with the optional porous PEEK portion omitted;

FIGS. 10A-10E illustrate various views of an exemplary insertion instrument and method for inserting the implant of FIG. 4A; and

FIGS. 11A-11C illustrate various views of an exemplary inserter and drill guide instrument for inserting an implant.

 DETAILED DESCRIPTION OF THE INVENTION

Certain terminology is used in the following description for convenience only and is not limiting. The words “right”, “left”, “lower” and “upper” designate directions in the drawings to which reference is made. The words “inwardly” or “distally” and “outwardly” or “proximally” refer to directions toward and away from, respectively, the geometric center of the implant and related parts thereof. The words, “anterior”, “posterior”, “superior,” “inferior” and related words and/or phrases designate preferred positions and orientations in the human body to which reference is made and are not meant to be limiting. The terminology includes the above-listed words, derivatives thereof and words of similar import.

Similar reference numerals will be utilized throughout the application to describe similar or the same components of each of the preferred embodiments of the implant described herein and the descriptions will focus on the specific features of the individual embodiments that distinguish the particular embodiment from the others.

Preferred embodiments of the present application are directed to an implant 10, 200 (“10-200”). It should be understood that while the various embodiments of the implant 10-200 will be described in connection with spinal surgery, those skilled in the art will appreciate that the implant 10-200, as well as the components thereof, may be used for implantation into other parts of the body, including, for example, long bones or bones in knee, hip, shoulder, or other joint replacement or for bone augmentation.

The various embodiments of the implant 10-200 are preferably sized and configured to be implanted between adjacent vertebral bodies V. The implant 10-200 may be sized and configured to replace all or substantially all of an intervertebral disc space D between adjacent vertebral bodies V or only part of the intervertebral disc space D. In addition, the preferred implant 10-200 may be configured to replace an entire vertebral body V and related disc spaces D or multiple disc spaces D in a patient's spine, as would be apparent to one having ordinary skill in the art based upon a review of the present application. The implant 10-200 may be adapted for use in the anterior, antero-lateral, direct lateral, extra-foraminal, transforaminal, and posterior approaches for insertion into the spine.

The implant 10-200 of each of the preferred embodiments includes an interbody spacer portion 20, 220, 220′ (“20-220”) and a plate portion 50, 250, 250′, 250″, 250′″ (“50-250”). The spacer portion 20-220 is preferably sized and configured for implantation into the intervertebral disc space D between adjacent vertebral bodies V. The spacer portion 20-220 of each of the preferred embodiments includes a top surface 22, a bottom surface 24, a first side surface 26, a second side surface 28, a leading surface 30 and a trailing surface 32. The top and bottom surfaces 22, 24 are suitable for contacting and are adapted for being secured relative to the end plates of adjacent vertebral bodies V. The spacer portion 20-220 is preferably sized and configured to maintain and/or restore a desired intervertebral disc height between the adjacent vertebral bodies V. Accordingly, the top and bottom surfaces 22, 24 may include a series of teeth, ridges, spikes or other similar projections 25 to aid in securing the implant 10-200 to the endplates of the adjacent vertebral bodies V.

The top and bottom surfaces 22, 24 may also include a curved or a tapered surface to help provide an anatomical shape for mating with the patient's spine or to orient the endplates of the adjacent vertebral bodies V in a desired manner. The particular surface shape and curvature, taper or alternate surface feature in the anterior-posterior direction, as well as the particular surface shape and curvature, taper or alternate surface feature in the medial-lateral direction will depend upon the location where the implant 10-200 is intended to be implanted and/or surgeon preferences or whether the implant 10-200 is utilized in another area in the body.

The spacer portion 20-220 may also include one or more spacer boreholes, openings, windows or channels 34 for receiving bone graft material. For example, the implant 10-200 may include one or more vertical openings, windows or channels extending through the spacer portion 20-220 from the top surface 22 to the bottom surface 24 for insertion of bone graft material, such that bone growth is promoted through the vertical openings, windows or channels 34 following implantation of the implant 10-200. One or more spacer boreholes, openings, windows or channels 34 is especially preferred if the spacer portion 20-220 is constructed of a non-allograft or non-bone-growth material, such as Polyetheretherketone (“PEEK”).

The plate portion 50-250 is preferably coupled to the spacer portion 20-220 to provide increased implant stability during healing as well as to optimally orient the trajectory of bone fixation elements 70 during implantation.

The plate portion 50-250 of each of the preferred embodiments includes a top surface 52, a bottom surface 54, a first side surface 56, a second side surface 58, a leading surface 60 and a trailing surface 62. The plate portion 50-250 preferably contacts the trailing surface 32 of the spacer portion 20-220 and preferably does not extend beyond or does not increase greatly the vertical or lateral perimeter of the spacer portion 20-220. In this manner, the implant 10-200 has a low profile. Additionally, in this manner, the plate portion 50-250 is preferably entirely implanted within the intervertebral disc space D between the adjacent vertebral bodies V such that the plate portion 50-250 has little or no external profile (e.g., the plate portion 50-250 does not extend anterior beyond an edge of the disc space D). In this manner, little or no structure protrudes outside of the bounds of the disc space D or the profile of the vertebral bodies V, thereby limiting dysphasia and patient discomfort. In use, the plate portion 50-250 may be sized and configured so that the top and bottom surfaces 52, 54 of the plate portion 50-250 contact the endplates of the adjacent vertebral bodies V. Alternatively, the plate portion 50-250 may be sized and configured so that only the spacer portion 20-220 contacts the adjacent vertebral bodies V. For example, the height of the plate portion 50-250 may be small enough so that it does not contact the vertebral bodies V when connected to the spacer portion 20-220 in an implanted position.

The plate portion 50-250 may be coupled to the spacer portion 20-220 by any coupling mechanism now or hereafter known. For example, the spacer portion 20-220 may include one or more recesses 36 formed in the side or trailing surfaces for engaging one or more projections 64 extending from the plate portion 50-250. Preferably the spacer portion 20 includes a recess 36 formed in each of the side surfaces 26, 28 thereof for engaging projections 64 extending from the plate portion 50-250. The recesses 36 may extend completely from the top surface 22 to the bottom surface of the spacer portion 20 or may extend only partially from either the top or bottom surface 20, 22. Other coupling mechanisms for coupling the plate portion 50-250 to the spacer portion 20-220 are disclosed in International Application No. PCT/US2008/082473 filed on Nov. 5, 2008 and entitled, “Low Profile Intervertebral Implant”, the contents of which are hereby incorporated by reference in their entirety.

The trailing surface 62 of the plate portion 50-250 preferably includes a tool engagement feature 80 for engaging one or more insertion tools. The tool engagement feature 80 may be in any form now or hereafter known for such purpose including one or more recesses formed in the trailing surface 62 of the plate portion 50-250, the recesses extending from top and bottom surfaces 52, 54, respectively, for engaging arms of the insertion tool. Alternatively, the tool engagement feature 80 may be a threaded bore (not shown) formed in the trailing surface 62 of the plate portion 50-250 for engaging a threaded stem extending from the insertion tool, etc.

The implant 10-200 preferably includes one or more bone fixation holes 40 for receiving one or more bone fixation elements 70, preferably bone screws so that, in use, after the implant 10-200 has been inserted into the intervertebral disc space D between adjacent vertebral bodies V, the implant 10-200 may be secured to the adjacent vertebral bodies V. The bone fixation elements 70 preferably include a threaded shaft 72 and a partially spherical head portion 74 that is generally smooth where it contacts the bone fixation hole 40. The threaded shaft 72 may be self-drilling, i.e. does not necessitate the drilling of pilot holes, but are not so limited. The bone fixation elements 70 are not limited to bone screws 70 and may be comprised of a helical nail, a distally expanding nail or screw, etc. The bone fixation holes 40 are preferably sized and configured so that the head portion 74 of the bone fixation elements 70 do not protrude proximally beyond the trailing surface 62 of the plate portion 50, when the bone fixation elements 70 have been fully implanted.

The bone fixation holes 40 preferably include a curved or frusta-spherical surface for contacting an underside of the generally smooth or frusta-spherical surface of the head portion 74 of the bone fixation elements 70 so that the bone fixation elements 70 can polyaxially rotate with respect to the plate portion 50-250 and a variety of trajectory angles can be chosen for the bone fixation elements 70 according to surgeons' preferences or needs as well as to enable the implant 10-200 to settle during healing.

The plate portion 50-250 preferably includes first and second bone fixation holes 40 for receiving first and second bone fixation elements 70 with the first bone fixation element 70 being angled upwardly for engaging the superior vertebral body V and the second bone fixation element 70 being angled downwardly for engaging the inferior vertebral body V. That is, the bone fixation holes 40 preferably have a longitudinal axis 41 that is oriented obliquely with respect to the implant 10-200 so that the bone fixation elements 70 form a fastener angle with respect to the top and bottom surfaces 22, 24 of the spacer portion 20 wherein bone fixation angle may be in the range between twenty degrees (20°) and sixty degrees (60°), and more preferably between thirty degrees (30°) and fifty degrees (50°). The bone fixation angle may be the same for all of the holes 40 or may be different for each of the holes 40. In addition, the bone fixation holes 40 may be directed inwardly toward the center of the implant 10-200 or outwardly away from the center of the implant 10-200, preferably at a lateral bone fixation angle α so that the bone fixation elements 70 extend laterally inward toward a center plane of the implant 10-200 or laterally outward away from the center plane of the implant 10-200. The lateral bone fixation angle α may be in the range between plus sixty degrees (60°) and minus sixty degrees (−60°), preferably between zero degrees (0°) and plus or minus thirty degrees (30°), and more preferably about plus or minus fifteen degrees (15°). The lateral bone fixation angle α may be the same for all holes 40 or may be different for each hole 40. However, as would be understood by one of ordinary skill in the art based upon a reading of this disclosure, a plurality of potential angles is possible since the bone fixation elements 70 are polyaxial, as will be described in greater detail below.

It should be understood however that the implant 10-200 may include three, four, five or more bone fixation holes 40 configured to receive a corresponding number of bone fixation elements 70 in any number of configurations. In addition, the number of bone fixation elements 70 extending from the top and bottom surfaces 22, 24 may be varied and the number of bone fixation elements 70 extending from the top surface 22 need not equal the number of bone fixation elements 70 extending from the bottom surface 24.

Exit openings for the bone fixation holes 40 preferably are formed at least partially in the top or bottom surfaces 52, 54 of the plate portion 50-250. The exit openings may also be formed at least partially or entirely in the top or bottom surfaces 22, 24 of the spacer portion 20-220. The bone fixation holes 40 may also include a partially spherical interior volume to accommodate the partially spherical geometry of the head portion 74 of the bone fixation elements 70 to enable a range of polyaxial orientations to be chosen for the bone fixation elements 70 with respect to the vertebral bodies V.

The implant 10-200 preferably also includes a retention mechanism for reducing the likelihood that the bone fixation elements 70 may postoperatively uncouple from the implant 10-200 and migrate from the disc space D. In use, the retention mechanism preferably covers at least a portion of the bone fixation holes 40 and hence the bone fixation elements 70 to prevent the bone fixation elements 70 from backing-out, as will be described in greater detail below.

The implant 10-200 including the spacer portion 20-220 and the plate portion 50-250 may be constructed of any suitable biocompatible material or combination of materials including, but not limited to one or more of the following metals such as titanium, titanium alloys, stainless steel, aluminum, aluminum alloy, magnesium, etc., polymers such as, PEEK, porous PEEK, carbon fiber PEEK, resorbable polymers, PLLA, etc., allograft, synthetic allograft substitute, ceramics in the form of bioglass, tantalum, Nitinol, or alternative bone growth material or some composite material or combination of these materials.

The spacer portion 20-220 may be formed of a different material than the plate portion 50-250. For example, the plate portion 50-250 may be formed of a metallic material such as, a titanium or a titanium alloy, and the spacer portion 20-220 may be formed of a non-metallic material such as, a polymer such as, PEEK, an allograft, a bioresorbable material, a ceramic, etc. Alternatively, the plate portion 50-250 and the spacer portion 20-220 may be formed from the same material. In addition, the plate portion 50-250 and spacer portion 20-220 may be integrally formed, pre-assembled or separately provided to a surgeon and assembled in the operating room.

As will be appreciated by one of ordinary skill in the art, the implant 10-200, or portions thereof, may also be coated with various compounds to increase bony on-growth or bony in-growth, to promote healing or to allow for revision of the implant 10-200, including hydroxyapatite, titanium-nickel, vapor plasma spray deposition of titanium, or plasma treatment to make the surface hydrophilic.

Referring to FIGS. 1A-2J, the intervertebral implant 10 of a first preferred embodiment includes the spacer portion 20, the plate portion 50, first and second bone fixation elements 70 and the retention mechanism. In the first preferred embodiment, the retention mechanism is in the form of a spring biased snapper element 110. More preferably, the plate portion 50 includes a borehole 112 in communication with each of the bone fixation holes 40 for receiving a spring 114 and a snapper element 116. The borehole 112 defines a longitudinal axis that intersects the longitudinal axis 41 of the bone fixation hole 40 and hence the bone fixation element 70. The intersection angle may be transverse, perpendicular or acute.

The snapper 116 preferably includes a first end 118 for contacting or interacting with the head portion 74 of the bone fixation element 70 and a second end 120 for receiving, contacting or interacting with the spring 114. The spring 114 is preferably sized and configured to bias the snapper 116 so that the snapper 116 protrudes into the bone fixation hole 40 and over the head portion 74 of the bone fixation element 70, once the bone fixation element 70 has been inserted into the bone fixation hole 40 to prevent back-out. The spring-biased snapper 116 is preferably secured within the borehole 112 via a pin or set screw 125. That is, the snapper 116 may include a groove or a recess 126 formed therein for mating with a pin or set screw 125, which is located within a borehole 125a. The interaction of the pin or set screw 125 and the groove or recess 126 preventing the snapper 116 from falling out of the borehole 112. For example, the snapper 116 preferably includes a rounded milled slot 126 and the pin or set screw 125 may be threaded and preferably includes a form fit so that the snapper 116 may be received and caught inside of the slot 126 formed in the snapper 116. Other mechanism for securing the spring-biased snapper 116 to the plate portion 50 may be used.

In the first preferred embodiment, the plate portion 50 also includes first and second stops 65, wherein the first stop 65 protrudes superiorly from the top surface 52 of the plate portion 50 for contacting the superior vertebral body V and the second stop 65 protrudes inferiorly from the bottom surface 54 of the plate portion 50 for contacting the inferior vertebral body V. Incorporation of more or less stops 65 is envisioned. Incorporation of the first and second stops 65 facilitates fully seating the implant 10 with respect to the adjacent vertebral bodies V regardless of the irregular anatomy of a patient's spine, which often characterizes the outer surface of the vertebral bodies V. The stops 65 are preferably integrally formed on the plate portion 50.

In use, the stops 65 are configured to abut the anterior aspects of the vertebral bodies V during implantation, although the stops 65 may abut the lateral or antero-lateral aspects of the vertebral bodies V depending upon the surgical procedure and insertion path being utilized. The stops 65 assist in preventing over-insertion of the implant 10 during implantation and assist in securing the position of the implant 10 during insertion of the bone fixation elements 70, as will be described in greater detail below. In part, due to the disposition of the stops 65, the implant 10 generally has a zero-profile external to the disc space D at least along a cranial-caudal midline, because the trailing surface 62 of the plate portion 50 can be designed to be convex to match the disc space D. Referring to FIGS. 2E-2J, a distal surface 65a of the stops 65 can be configured to embed at least partially into the vertebral bodies V during impaction to further reduce the profile of the plate portion 50 exterior to the disc space D, if so desired. For example, as shown in FIG. 2E, the distal surface 65a of the stops 65 may include a pyramid shaped projection or tooth 66 extending therefrom for embedding at least partially into the vertebral bodies V during impaction. Alternatively, the distal surface 65a of the stops 65 may include a plurality of projections or teeth 67 (as shown in FIG. 2F), a vertical blade type projection 68 (as shown in FIGS. 2G and 2H) or a transverse blade type projection 69 (as shown in FIGS. 2I and 2J) extending therefrom for embedding at least partially into the vertebral bodies V during impaction.

In operation, a surgeon prepares a pathway or channel to the disc space D, performs at least a partial discectomy, and inserts the implant 10 including the spacer portion 20 and the plate portion 50 into the disc space D until the stops 65 contact the adjacent vertebral bodes V. After the surgeon has chosen a desirable entry angle for the bone fixation elements 70, the surgeon advances the first and second bone fixation elements 70 into and through the bone fixation holes 40 at the selected angle, with or without the prior formation of pilot holes. Advancement of the bone fixation elements 70 into the bone fixation holes 40 causes the head portion 74 of the bone fixation elements 70 to contact the inner spherical portions of the bone fixation holes 40 and tends to draw the vertebral bodies V into alignment as opposed to resulting in the over-insertion of the implant 100 since the stops 65 guide the movement of the vertebral bodies V during bone fixation manipulation. That is, because the stops 65 contact the adjacent vertebral bodies V and prevents over-insertion of the implant 10 into the disc space D, advancement of the bone fixation elements 70 tends to pull and/or reposition the adjacent vertebral bodies V together to promote fusion. The bone fixation elements 70 are advanced until the vertebral bodies V are optimally aligned and the head portions 74 of the bone fixation elements 70 are advanced into the spherical portions of the bone fixation holes 70.

As the bone fixation elements 70 advance through the bone fixation holes 40, the underside of the head portion 74 of the bone fixation elements 70 contact the first end 118, preferably a tapered end portion 117, of the snapper elements 116 that protrude into the bone fixation holes 40, thereby urging the snapper elements 116 to recoil upon the spring 114 and retracting the snapper elements 116 from the bone fixation holes 40 so that the bone fixation elements 70 can be implanted. Once the head portions 74 of the bone fixation elements 70 advance past the tapered end portion 117 of the snapper elements 116, the spring 114 forces the snapper elements 116 back to their initial position in which the snapper elements 116 protrude at least partially into the bone fixation holes 40. In this position, the first end 118 of the snapper element 116 is designed to cover at least a portion, contact and/or interact with the top surface of the head portions 74 of the bone fixation elements 70 to block the head portions 74 of the bone fixation elements 70 and limit the bone fixation elements 70 from backing-out of the bone fixation holes 40. Specifically, the first end 118 of the snapper element 110 preferably extends into the bone fixation hole 40 such that the head portion 74 of the bone fixation element 70 is unable to move out of the bone fixation hole 40 without impacting the first end 118.

Post implantation, the bone fixation elements 70 are preferably free to toggle to allow for settling during postoperative healing. Referring to FIGS. 3A and 3B, if a surgeon decides the placement of the implant 10 is not optimal, adjustments can be made by compressing the snapper elements 116 with a blunt instrument or a sleeve thereby allowing the bone fixation elements 70 to be removed. For example, a removal instrument 1000 may include an inner shaft 1010 for engaging the bone fixation element 70 and an outer shaft 1020 for contacting and recoiling the snapper element 116 so that the bone fixation element 70 may be removed from the plate portion 50.

Referring to FIGS. 4A-5B, the intervertebral implant 200 of a second preferred embodiment includes the interbody spacer portion 220, the plate portion 250, first and second bone fixation elements 70 and the retention mechanism. In the second preferred embodiment, the retention mechanism is in the form of a propeller 310 moveable, more preferably rotatable, between a first position (illustrated in FIGS. 4A, 4B and 5A) and a second position (illustrated in FIGS. 4C, 4D and 5B). In the first position, the propeller 310 does not interfere with first and second bone fixation holes 40 so that the first and second bone fixation elements 70 can be inserted into the adjacent vertebral bodies V. In the second position, the propeller 310 blocks or covers at least a portion of the bone fixation holes 40 and hence at least a portion of the implanted bone fixation elements 70 to prevent backing-out.

The propeller 310 is preferably preassembled or pre-attached to the plate portion 250. The propeller 310 may be attached to the plate portion 250 by any coupling mechanism now or hereafter known in the art including those described below. In the second preferred embodiment, the propeller 310 is preassembled to the plate portion 250 via a retaining screw 320 that interfaces with a threaded borehole (not shown) disposed between the bone fixation holes 40 formed in the plate portion 250. The retaining screw 320 may extend into and be threadably coupled to the spacer portion 220, but is not so limited. Alternatively, the retaining screw 320 may be securely coupled with respect to the plate portion 250 by a cross-pinned shaft, a rivet, a helical wedge attached to the shaft of the retaining screw 320, etc. The propeller 310 includes first and second ends 312, 314 defining a longitudinal axis that is generally transverse to the longitudinal axis of the retaining screw 320.

The propeller 310 and the retaining screw 320 are preferably rotatable through a range of about ninety degrees (90°) from the first position to the second position. In the first position, the longitudinal axis of the propeller 310 is oriented generally parallel to a longitudinal axis of the implant 200 and generally parallel to the cranial-caudal axis of the spine so that the propeller 310 does not interfere with the bone fixation holes 40 or bone fixation elements 70 to enable insertion of the bone fixation elements 70 into the adjacent vertebral bodies V. In the second position, the longitudinal axis of the propeller 310 is generally oriented perpendicular to the cranial-caudal axis of the spine so that the propeller 310 blocks or covers at least a portion of the bone fixation holes 40 and the bone fixation elements 70 to prevent backing-out. That is, in the second position, the propeller 310 covers at least a portion of the head portion 74 of the bone fixation elements 70 while in the first position, the propeller 310 permits insertion of the bone fixation elements 70 into the bone fixation holes 40 and into the adjacent vertebral bodies V.

The retaining screw 320 preferably includes an engagement feature 321 for engaging an insertion instrument 500, as will be described in greater detail below, to rotate the retaining screw 320 and the propeller 310 to and between the first and second positions. The retaining screw 320 and the propeller 310 are coupled to one another and preferably rotate together via a two point interference fit between the outer diameter of the retaining screw 320 and the diameter of a counterbore (not shown) through the propeller 310.

The plate portion 250 preferably includes a tapered recess 330 that forms a guide ramp so that in the second position, the propeller 310 preferably lies flush with the trailing surface 62 of the plate portion 250 (as best shown in FIG. 4D). Accordingly, in the first position (FIGS. 4A and 4B), the propeller 310 extends from the trailing surface 62 of the plate portion 250 and in the second position (FIGS. 4C and 4D), the anterior surface of the propeller 310 lies generally flush or somewhat recessed with respect to the trailing surface 62. Therefore, in an implanted configuration when the propeller 310 is in the second position, the entire implant 200, including the propeller 310, lies within the bounds of the patient's spine or posteriorly relative to the anterior aspect of the vertebrae V.

In operation, a surgeon prepares a pathway or channel to the disc space D, performs at least a partial discectomy, and inserts the implant 200 including the spacer portion 220 and the plate portion 250 into the disc space D with the propeller 310 in the first position. In the first position, the propeller 310 is sized to act as a stop during implantation of the implant 200 to prevent over-insertion of the implant 200, as well as to secure the position of the implant 200 during the insertion of the bone fixation elements 70. Specifically, the ends 312, 314 of the propeller 310 contact and/or engage the adjacent vertebral bodies V to mechanically block further insertion of the implant 200 into the disc space D (as best shown in FIG. 5A).

After the surgeon has chosen a desirable entry angle for the bone fixation elements 70, the surgeon advances the first and second bone fixation elements 70 into and through the bone fixation holes 40 at the selected angle, with or without the prior formation of pilot holes. Advancement of the bone fixation elements 70 into the bone fixation holes 40 causes the head portion 74 of the bone fixation elements 70 to contact the inner spherical portions of the bone fixation holes 40 and tends to draw the vertebral bodies V into alignment as opposed to resulting in the over-insertion of the implant 200 since the propeller 310 preferably guides the movement of the vertebral bodies V during bone fixation manipulation. The bone fixation elements 70 are advanced until the vertebral bodies V are optimally aligned and the head portions 74 of the bone fixation elements 70 are advanced into the spherical portions of the bone fixation holes 70. The retaining screw 320 and the propeller 310 are then rotated ninety degrees (90°) from the first position to the second position, guided by the recesses 330 formed in the trailing surface 62 of the plate portion 250, by mating an insertion instrument to the instrument engagement feature 321 on the retaining screw 320. As the retaining screw 320 is rotated from the first position to the second position, the retaining screw 320 preferably advances distally, based on the pitch of the threading formed on its shaft, and the propeller 310 rotates down the guide ramp formed by the recesses 330 and comes to rest therein while overlying the head portions 74 of the bone fixation elements 70. The shape of the guide ramp formed by the recesses 330 preferably stops the propeller 310 from over rotating past the second position, such that the ends of the propeller 310 at least partially cover the head portions 74 of the bone fixation elements 70. As such, the bone fixation elements 70 are prevented from backing-out of the plate portion 250 and the spacer portion 220 by the propeller 310.

Post implantation, the bone fixation elements 70 are preferably free to toggle to allow for settling during postoperative healing. If a surgeon decides the placement of the implant 200 is not optimal, adjustments can be made by rotating the propeller 310 back to the first position, thereby unblocking the head portions 74 of the bone fixation elements 70 and allowing adjustments thereto.

Referring to FIGS. 6A and 6B, a second preferred embodiment of the plate portion 250′ for use with implant 200 is illustrated. In the second preferred embodiment of the plate portion 250′, the bone fixation holes 40 include a protruding thread blocking mechanism 350 that is sized and configured to permit the threaded advancement of the first and second bone fixation elements 70 with respect to the bone fixation holes 40 until the proximal most thread 73 formed on the shaft 72 of the bone fixation element 70 advances distally past the thread blocking mechanism 350, at which point the distal surface of the thread blocking mechanism 350 contacts a proximal side of the proximal most thread 73 to inhibit the first and second bone fixation elements 70 from backing-out of the bone fixation holes 40. The thread blocking mechanism 350 may assume the form of a raised ridge or interrupted ring of material or a variety of other protruding features configured to allow the proximal most thread 73 of the bone fixation element 70 to advance to a point from which retreat in the opposite direction is inhibited. Alternatively, the thread blocking mechanism 350 can be disposed within the bone fixation holes 40 to block the proximal surface of the head portions 74 of the bone fixation elements 70, as opposed to the proximal most threads 73. Alternatively, the thread blocking mechanism 350 can be configured to engage a corresponding indentation (not shown) formed on the sides of the head portions 74 of the bone fixation elements 70.

The bone fixation elements 70 may further include an undercut 75 between the proximal most thread 73 and the distal portion of the head portion 74 for enabling the bone fixation element 70 to generally rotate freely after being fully seated in the bone fixation hole 40 to thereby permit lagging of the vertebral bodies V with respect to the implant 200 during implantation.

In operation, the implant 200 is positioned between the adjacent vertebral bodies V and the bone fixation elements 70 are advanced into the bone fixation holes 40 until the proximal most thread 73 formed on the shaft portion 72 of the bone fixation elements 70 advance past the protruding thread blocking mechanism 350. The bone fixation elements 70 are fully seated with respect to the plate portion 250′ in this position. The distal surface of the thread blocking mechanism 350 contacts the proximal side of the proximal most thread 73 formed on the shaft portions 72 of the bone fixation elements 70 to limit the bone fixation elements 70 from backing-out of the bone fixation holes 40. The bone fixation elements 70 are generally free to rotate after being fully seated due to the inclusion of the undercuts 75 between the proximal most thread 73 and the head portion 74 of each bone fixation elements 70 to permit lagging of the vertebral bodies V with respect to the implant 200 during implantation. The propeller 310 can then be utilized in conjunction with the thread blocking mechanism 350 to secure the position of the implant 200 during the insertion of the bone fixation elements 270, as well as to add additional back-out prevention. Alternatively, it is envisioned that the thread blocking mechanism 350 can be incorporated into the first preferred embodiment of the implant 10.

Referring to FIGS. 7A and 7B, a third preferred embodiment of the plate portion 250″ for use with the implant 200 is illustrated. The third preferred embodiment of the plate portion 250″ includes an alternate coupling mechanism for coupling the propeller 310″ to the plate portion 250″. In this embodiment, the propeller 310″ includes a plurality of slots 317″ extending from a distal end 316″ of the propeller 310″ so that the propeller 310″ includes a plurality of spring-like fingers 315″ oriented along an axis that extends distally, generally perpendicular to the longitudinal axis of the ends 312″, 314″ of the propeller 310″. The spring fingers 315″ preferably include an outwardly extending flange 318″ at the distal end 316″ thereof. The plate portion 250″ preferably includes a non-threaded borehole 263″ disposed between the bone fixation holes 40. The non-threaded borehole 263″ preferably includes one or more ramps 263a″ and one or more steps 263b″ for interfacing with the spring fingers 315″ for securing the propeller 310″ to the plate portion 250″.

An optional retaining clip 340″, such as a wishbone clip formed of, for example, elgiloy, may be mounted in the borehole 263″ to further assist in securing the propeller 310″ to the plate portion 250″ by allowing insertion of the propeller 310″ into the borehole 263″ while providing additional protection against the propeller 310″ from backing-out of the borehole 263″.

In operation, the propeller 310″ is assembled to the plate portion 250″ by inserting the spring fingers 315″ into the borehole 263″ until the propeller 310″ snaps into the borehole 263″, retaining the propeller 310″ therein. That is, as the spring fingers 315″ advance into the borehole 263″, the tapered flanges 318″ formed on the distal end 316″ of the propeller 310″ and the spring fingers 315″ compress so that the fingers 315″ pass through the optional retaining clip 340″ after which the spring fingers 315″ partially spring back outwardly. The retaining clip 340″ may additionally flex slightly outwardly as the flange 318″ passes therethrough, after which the retaining clip 340″ springs back to its initial configuration. As the spring fingers 315″ continue to advance into the borehole 263″, the fingers 315″ pass over the step 263b″ and subsequently flex outwardly to their non-deflected configuration adjacent the ramp 263a″. In this manner, the propeller 310″ is prevented from backing-out through the borehole 263″ via interaction between the flanges 318″ and the step 263b″.

Referring to FIG. 8, a fourth preferred embodiment of the plate portion 250′ for use with the implant 200 is illustrated. The fourth preferred embodiment of the plate portion 250′″ includes a third alternate coupling mechanism for coupling the propeller 310′″ to the plate portion 250′″. In this embodiment, the non-threaded borehole 263′″ includes a first ramp 263a′″, a first step 263b′″, a second preferred helical ramp 263c′″, and a second step 263d″″ as one moves from the trailing surface 62 of the plate portion 250′. The configuration of the propeller 310′″ is substantially identical to the propeller 310″ of the second exemplary coupling mechanism described above.

In operation, the propeller 310′ is assembled to the plate portion 250′″ by inserting the spring fingers 315′″ into the non-threaded borehole 263′″ until the propeller 310′ snaps into the borehole 263′, which retains the propeller 310′″ therein. As the spring fingers 315′″ advance into the borehole 263′″, the spring fingers 315′ compress as the tapered flanges 318′″ pass along the first ramp 263a′″ and over the first step 263b′″, at which point the spring fingers 315′″ and the flanges 318′″ partially spring outwardly thereby securing the propeller 310′ to the plate portion 250′″. The propeller 310′″ is prevented from backing-out through the borehole 263′″ via interaction between the flanges 318′″ and the first step 263a′″. In addition, as the propeller 310′″ is moved from the first position to the second position, the spring fingers 315′″ further advance into the borehole 263′″, wherein the flange 318′″ is guided by the preferred helically formed second ramp 263c′″, until the flange 318′″ passes over the second step 263d′″. The spring fingers 315′″ and the flanges 318′″ flex outwardly into their non-deflected configuration to block the propeller 310′″ from backing-out through the borehole 263′″ via interaction between the flanges 318′″ and the second step 263d′″.

Referring to FIGS. 9A-9C, an alternate embodiment of the spacer portion 220′ for use with the first and second preferred embodiments of the intervertebral implant 10-200 (second preferred embodiment illustrated) includes a centralized porous PEEK region 422 concentrically surrounded by a conventional PEEK portion 420.

In operation, the implant 200 is implanted and secured within the disc space D in a similar manner as previously described. The central porous PEEK portion 422 of the spacer portion 220′ has a porosity that provides a suitable pathway through which blood is able to flow and bone is able to grow to assist in promoting fusion with and between the adjacent vertebral bodies V. The porous PEEK portion 422 may extend from the top surface 22 to the bottom surface 24 of the spacer portion 220′. Alternatively, the spacer portion 220′ may include a bridge 424. When the spacer portion 220′ includes the bridge 424, first and second blind boreholes 426, 428 preferably extend from the top and bottom surfaces 22, 24, respectively, to the bridge 424. The blind boreholes 426, 428 may include tapered sidewalls 430 such that a diameter of the blind boreholes 426, 428 increases toward the center of the spacer portion 220′. The bridge 424 may be formed of the same material as the rest of the spacer portion 220′, but is preferably constructed of porous PEEK. Alternately, the bridge 424 may be removable, e.g., capable of being popped out of the spacer portion 220′ to provide an axial throughbore. In operation, the blind boreholes 426, 428 are preferably filled with bone graft or other fusion promoting material and the implant 200′ is implanted into the disc space D between the adjacent vertebral bodies V. The optional tapered sidewalls 430 of the blind bores 426, 428 facilitate securing the position of the implant 200′ within the disc space D as fusion occurs into the blind boreholes 426, 428.

Referring to FIGS. 10A-10E, an exemplary insertion instrument 500 and method for inserting the implant 200 will now be described. In connection with the exemplary method, the propeller 310 will be described and illustrated as unattached to the plate portion 250. However the exemplary method can be easily adapted to operate with the propeller 310 pre-attached to the plate portion 250 or adapted to operate with the first preferred embodiment of the implant 10, as would be apparent to one having ordinary skill in the art based upon a review of the present application.

The insertion instrument 500 is configured to couple to the propeller 310, to couple to the plate portion 250, to insert the implant 200 at least partially into the disc space D, to permit insertion of the bone fixation elements 70 into the bone fixation holes 40, to secure the propeller 310 to the plate portion 250, if necessary, and to rotate the propeller 310 from the first position to the second position, if necessary.

The insertion instrument 500 preferably includes an inner shaft 520 and an outer tubular member 530. The inner shaft 520 preferably includes a distal engagement feature 525, such as a star drive, for interfacing with the engagement feature 321 formed on the retaining screw 320. The outer tubular member 530 preferably includes a distal engagement feature 535 for interfacing with a corresponding engagement feature (not shown) formed on the plate portion 250. Accordingly, the instrument 500 retains the propeller 310 by securing the engagement feature 525 formed on the inner shaft 520 of the instrument 500 to the propeller 310. The instrument 500 retains the implant 200 by grasping the plate portion 250 with the engagement feature 535 formed on the outer tubular member 530.

The inner shaft 520 is configured to translate within the outer tubular member 530 along a longitudinal axis 501 of the instrument 500. Accordingly, the inner shaft 520, and hence the propeller 310, may be translated proximally with respect to the outer tubular member 530, and hence with respect to the implant 200. For embodiments where the propeller 310 is unattached to the plate portion 250 and where the plate portion 250 does not include one or more stops, the instrument 500 may also include one or more stops (not shown) to prevent over-insertion of the implant 200 into the disc space D as well as to secure the position of the implant 200 with respect to the disc space D during the implantation of the bone fixation elements 70.

In operation, the surgeon inserts the implant 200 into the disc space D by using the instrument 500 to advance the implant 200 into the disc space D between the adjacent vertebral bodies V until one or more stops (not shown) abut the anterior (or lateral or antero-lateral) aspects of the vertebral bodies V. The bone fixation elements 70 are then inserted through the bone fixation holes 40 and into the vertebral bodies V while lagging of the implant 200 is limited by the interaction of the stops with the vertebral bodies V.

If unattached, the propeller 310 and the retaining screw 320 may then be advanced into a corresponding borehole 263 formed in the plate portion 250 by translating the inner shaft 520 distally with respect to the outer tubular member 530. The inner shaft 250 is then rotated so that the propeller 310 moves from its first position to its second position to prevent back-out of the implanted bone fixation elements 70. The instrument 500 is then decoupled from the propeller 310 and the retaining screw 320.

Referring to FIGS. 11A-11C, an optional inserter and drill guide instrument 600 can be utilized to insert any of the previously described implants 10-200 and to align the trajectory of an awl, drill, driver instrument, etc. for pilot hole formation and/or bone fixation element insertion. The inserter and drill guide instrument 600 includes a pair of arms 610, 615 extending from a pair of handles 620, 625 that are coupled at a pivot point 630. The arms 610, 615 include aiming barrels 612, 616 at their distal ends, respectively, for aligning the trajectory of the awl, drill, bone fixation elements, etc. The barrels 612, 616 include guide ribs 613, 617, respectively, disposed on their outer surface for interfacing with a key 625 formed in the bone fixation holes 40 of the implant 200. The interfacing guide ribs 613, 617 and keys 625 are configured to limit rotation of the implant 10-200 relative to the instrument 600, a feature that is especially preferred for implants 10-200 having only two bone fixation holes 40.

In operation, the arms 610, 615 of the inserter and drill guide instrument 600 are opened by squeezing the handles 620, 625 together and the barrels 612, 616 are inserted into the bone fixation holes 40 formed in the plate portion 250 such that the guide ribs 613, 617 interface with the keys 625. Upon secure grasping of the implant 10-200, the arms 610, 615 are locked into place and the instrument 600 may be used to insert the implant 10-200 into an at least partially cleared out disc space D between the vertebral bodies V. The barrels 612, 616 can then be used to align the trajectory of an awl, drill, etc. to form pilot holes for the bone fixation elements 70 or may align the trajectory of the bone fixation elements 70 in the case where self-drilling bone fixation elements 70 are utilized. Subsequent to the implantation of the bone fixation elements 70, the arms 610, 615 are unlocked and the inserter and drill guide instrument 600 is decoupled from the implant assembly.

While the foregoing description and drawings represent the preferred embodiments of the present invention, it will be understood that various additions, modifications, combinations and/or substitutions may be made therein without departing from the spirit and scope of the present invention as defined in the accompanying claims. In particular, it will be clear to those skilled in the art that the present invention may be embodied in other specific forms, structures, arrangements, proportions, and with other elements, materials, and components, without departing from the spirit or essential characteristics thereof. One skilled in the art will appreciate that the invention may be used with many modifications of structure, arrangement, proportions, materials, and components and otherwise, used in the practice of the invention, which are particularly adapted to specific environments and operative requirements without departing from the principles of the present invention. In addition, features described herein may be used singularly or in combination with other features. The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims, and not limited to the foregoing description.

Claims

1. An implant for insertion into an intervertebral disc space between superior and inferior vertebral bodies, the implant comprising:

a spacer portion including a top surface configured to face the superior vertebral body, and a bottom surface configured to face the inferior vertebral body;
a plate portion coupled to the spacer portion, the plate portion including a top surface, and a bottom surface, the plate portion further including a first bone fixation hole configured to receive a first bone fixation element along a first insertion direction, the plate portion further including a first borehole intersecting with the first bone fixation hole; and
a first spring biased snapper element disposed at least partially in the first borehole, the first spring biased snapper element configured to prevent the first bone fixation element from backing-out of the first bone fixation hole along a first back-out direction that is opposite the first insertion direction when the first bone fixation element is inserted into the first bone fixation hole, the first spring biased snapper element including a first end that defines a tapered top surface and a flat bottom surface;
wherein the first spring biased snapper element is moveable to a position such that at least a portion of the first end protrudes into the first bone fixation hole so that when the first bone fixation element is inserted into the first bone fixation hole the flat bottom surface of the first spring biased snapper element at least partially is aligned with the first bone fixation element along the first back-out direction.

2. The implant of claim 1, wherein a height of the plate portion is substantially equal to a height of the spacer portion and a width of the plate portion is substantially equal to a width of the spacer portion.

3. The implant of claim 1, wherein the spacer portion includes a first side surface, a second side surface, a first recess formed in the first side surface and a second recess formed in the second side surface, the first and second recesses configured to engage first and second projections, respectively, extending from the plate portion.

4. The implant of claim 1, wherein the spacer portion further includes a centralized region comprising a first material concentrically surrounded by a portion comprising a second material that is different from the first material.

5. The implant of claim 4, wherein the centralized region extends from the top surface to the bottom surface.

6. The implant of claim 4, wherein the first material is more porous than the second material.

7. The implant of claim 1, wherein the first bone fixation hole is angled such that when the first bone fixation element is received within the first bone fixation hole the first fixation element engages the superior vertebral body.

8. The implant of claim 1, wherein the first spring biased snapper element is biased to the position.

9. The implant of claim 1, wherein:

the plate portion further includes a second bone fixation hole configured to receive a second bone fixation element along a second insertion direction, the plate portion further including a second borehole intersecting with the second bone fixation hole; and
a second spring biased snapper element disposed at least partially within the second bore hole, the second spring biased snapper element configured to prevent the second bone fixation element from backing-out of the second bone fixation hole along a second back-out direction that is opposite the second insertion direction, when the second bone fixation element is inserted into the second bone fixation hole, the second spring biased snapper element including a first end that includes a tapered top surface and a flat bottom surface;
wherein the second spring biased snapper element is moveable to a position such that at least a portion of the first end of the second spring biased snapper element protrudes into the second bone fixation hole so that when the second bone fixation element is inserted into the second bone fixation hole the flat bottom surface of the second spring biased snapper element at least partially covers the second bone fixation element with respect to the second back-out direction.

10. The implant of claim 9, wherein each of the first and second spring biased snapper elements includes a spring and a snapper element, the snapper element including the first end that protrudes into the first and second bone fixation holes, and a second end configured to interact with the spring.

11. The implant of claim 10, wherein the first and second spring biased snapper elements are secured within the first and second boreholes, respectively, via first and second pins, respectively.

12. The implant of claim 9, wherein the position of the first and second spring biased snapper elements is a first position, and insertion of the first and second bone fixation elements causes the first and second spring biased snapper elements to move from their respective first positions to respective second positions in which the first and second spring biased snapper elements are removed from the first and second bone fixation holes.

13. The implant of claim 9, wherein the position of the first and second spring biased snapper elements is a first position, and insertion of the first and second bone fixation elements causes a head portion of the first and second bone fixation elements to contact the first and second spring biased snapper elements, respectively, to cause the first and second spring biased snapper elements to recoil from their first positions to respective second positions.

14. The implant of claim 13, wherein further insertion of the first and second bone fixation elements causes the head portions of the first and second bone fixation elements to move distally of the first and second spring biased snapper elements resulting in the first and second snapper elements automatically moving from their second position to their first positions.

15. The implant of claim 9, further comprising first and second stops configured to prevent over-insertion of the implant during implantation and configured to assist in securing a position of the implant during insertion of the first and second bone fixation elements, the first stop extending superiorly of the top surface of the plate portion such that the first stop is configured to contact the superior vertebral body, the second stop extending inferiorly of the bottom surface of the plate portion such that the second stop is configured to contact the inferior vertebral body.

16. The implant of claim 15, wherein the first and second stops are integrally formed with the plate portion.

17. The implant of claim 15, wherein the first and second stops each include a distal surface that is configured to at least partially embed into the respective superior or inferior vertebral body.

18. The implant of claim 17, wherein the distal surface of each of the first and second stops includes a pyramid shaped projection or tooth configured to at least partially embed into the respective superior or inferior vertebral body.

19. The implant of claim 17, wherein the distal surface of each of the first and second stops includes a plurality of projections or teeth configured to at least partially embed into the respective superior or inferior vertebral body.

20. The implant of claim 17, wherein the distal surface of each of the first and second stops includes a vertical blade type projection configured to at least partially embed into the respective superior or inferior vertebral body.

21. The implant of claim 17, wherein the distal surface of each of the first and second stops includes transverse blade type projection configured to at least partially embed into the respective superior or inferior vertebral body.

22. The implant of claim 9, wherein the plate portion further includes a thread blocking mechanism that is configured to permit the advancement of the respective first or second bone fixation element into the respective first or second bone fixation hole to a desired depth, and once the respective first or second bone fixation element has reached the desired depth the thread blocking mechanism inhibits the respective first or second bone fixation element from backing out of the respective first or second bone fixation hole.

23. The implant of claim 22, wherein the desired depth is the point at which a distal surface of the thread blocking mechanism contacts a proximal side of the proximal most thread.

24. The implant of claim 22, wherein the thread blocking mechanism comprises a raised ridge.

25. The implant of claim 22, wherein the thread blocking mechanism comprises an interrupted ring.

26. The implant of claim 6, wherein the first material comprises porous PEEK and the second material comprises conventional PEEK.

27. The implant of claim 9, wherein the second bone fixation hole is angled such that when the second bone fixation element is received within the second bone fixation hole the second bone fixation element engages the inferior vertebral body.

28. The implant of claim 9, further comprising a mechanism configured to be actuated from a first configuration to a second configuration, such that when the mechanism is in the first configuration the mechanism is located at least partially within the first or second borehole to secure the respective first or second snapper element within the first or second borehole, and when the mechanism is in the second configuration the first or second snapper element is capable of being inserted into or removed from the respective first or second borehole.

29. The implant of claim 9, wherein the first and second spring biased snapper elements are biased to their respective positions.

30. An implant for insertion into an intervertebral disc space between superior and inferior vertebral bodies, the implant comprising:

a spacer portion including a top surface configured to face the superior vertebral body, and a bottom surface configured to face the inferior vertebral body;
a plate portion coupled to the spacer portion, the plate portion including a top surface, and a bottom surface, the plate portion further including a first bone fixation hole, a first borehole, and a second borehole, the first bone fixation hole configured to receive a first bone fixation element, the first borehole intersecting with the first bone fixation hole, and the second borehole being offset and open to the first borehole, the plate portion further including a second bone fixation hole, a third borehole, and a fourth borehole, the second bone fixation hole configured to receive a second bone fixation element, the third borehole intersecting with the second bone fixation hole, and the fourth borehole being offset and open to the third borehole;
a first spring biased snapper element positioned in the first borehole such that the first spring biased snapper element is moveable from a first position wherein a portion of the first spring biased snapper element protrudes into the first bone fixation hole to prevent the first bone fixation element from backing out of the first bone fixation hole, to a second position wherein the portion of the first spring biased snapper element is removed from the first bone fixation hole;
a second spring biased snapper element positioned in the third borehole such that the second spring biased snapper element is moveable from a first position wherein a portion of second the spring biased snapper element protrudes into the second bone fixation hole to prevent the second bone fixation element from backing out of the second bone fixation hole, to a second position wherein the portion of the second spring biased snapper element is removed from the second bone fixation hole;
a first mechanism that is located at least partially within the second borehole, the first mechanism moveable with respect to the first spring biased snapper element and configured to be positioned at least partially within the first borehole such that the first mechanism: 1) permits movement of the first spring biased snapper element between the first and second positions; and 2) prevents the first spring biased snapper element from exiting the first borehole entirely; and
a second mechanism that is located at least partially within the fourth borehole, the second mechanism moveable with respect to the second spring biased snapper element and configured to be positioned at least partially within the third borehole such that the second mechanism: 1) permits movement of the second spring biased snapper element between the first and second positions; and 2) prevents the second spring biased snapper element from exiting the third borehole entirely;
wherein the first and second spring biased snapper elements each include a first end that has a tapered top surface and a flat bottom surface such that when the first and second spring biased snapper elements are in their respective first positions and the first and second bone fixation elements are inserted into the first and second bone fixation holes, respectively, 1) the flat bottom surface of the first spring biased snapper element faces a head of the first bone fixation element such that back out of the first bone fixation element is prevented, and 2) the flat bottom surface of the second spring biased snapper element faces a head of the second bone fixation element such that back out of the second bone fixation element is prevented.

31. An implant for insertion into an intervertebral disc space between superior and inferior vertebral bodies, the implant comprising:

a spacer portion including a top surface configured to face the superior vertebral body, and a bottom surface configured to face the inferior vertebral body;
a plate portion coupled to the spacer portion, the plate portion including a top surface, and a bottom surface, the plate portion further including a first bone fixation hole, a first borehole, and a second borehole, the first bone fixation hole configured to receive a first bone fixation element, the first borehole intersecting with the first bone fixation hole, and the second borehole being offset and open to the first borehole, the plate portion further including a second bone fixation hole, a third borehole, and a fourth borehole, the second bone fixation hole configured to receive a second bone fixation element, the third borehole intersecting with the second bone fixation hole, and the fourth borehole being offset and open to the third borehole;
a first spring biased snapper element positioned in the first borehole such that the first spring biased snapper element is moveable from a first position wherein a portion of the first spring biased snapper element protrudes into the first bone fixation hole to prevent the first bone fixation element from backing out of the first bone fixation hole, to a second position wherein the portion of the first spring biased snapper element is removed from the first bone fixation hole;
a second spring biased snapper element positioned in the third borehole such that the second spring biased snapper element is moveable from a first position wherein a portion of second the spring biased snapper element protrudes into the second bone fixation hole to prevent the second bone fixation element from backing out of the second bone fixation hole, to a second position wherein the portion of the second spring biased snapper element is removed from the second bone fixation hole;
a first mechanism comprising a spring or a set screw, the first mechanism located at least partially within the second borehole, the first mechanism moveable with respect to the first spring biased snapper element and configured to be positioned at least partially within the first borehole such that the first mechanism: 1) permits movement of the first spring biased snapper element between the first and second positions; and 2) prevents the first spring biased snapper element from exiting the first borehole entirely; and
a second mechanism comprising a spring or a set screw, the second mechanism located at least partially within the fourth borehole, the second mechanism moveable with respect to the second spring biased snapper element and configured to be positioned at least partially within the third borehole such that the second mechanism: 1) permits movement of the second spring biased snapper element between the first and second positions; and 2) prevents the second spring biased snapper element from exiting the third borehole entirely.
Referenced Cited
U.S. Patent Documents
424836 April 1890 Thompson
1105105 July 1914 Sherman
1200797 October 1916 Barbe
2151919 March 1939 Jacobson
2372888 April 1945 Edward
2621145 December 1952 Sano
2782827 February 1957 Joseph
2906311 September 1959 Boyd
2972367 February 1961 Wootton
3062253 November 1962 Melvin
3272249 September 1966 Houston
3350103 October 1967 Ahlstone
3561075 February 1971 Selinko
3579831 May 1971 Stevens et al.
3707303 December 1972 Petri
3810703 May 1974 Pasbrig
3899897 August 1975 Boerger et al.
3945671 March 23, 1976 Gerlach
4017946 April 19, 1977 Soja
4056301 November 1, 1977 Norden
4123132 October 31, 1978 Hardy
4135506 January 23, 1979 Ulrich
4278120 July 14, 1981 Hart et al.
4280875 July 28, 1981 Werres
4285377 August 25, 1981 Hart
4288902 September 15, 1981 Franz
4297063 October 27, 1981 Hart
4299902 November 10, 1981 Soma et al.
4388921 June 21, 1983 Sutter et al.
4484570 November 27, 1984 Sutter et al.
4488543 December 18, 1984 Tornier
4501269 February 26, 1985 Bagby
4503848 March 12, 1985 Caspar et al.
4512038 April 23, 1985 Alexander et al.
4553890 November 19, 1985 Gulistan
4599086 July 8, 1986 Doty
4627853 December 9, 1986 Campbell et al.
4640524 February 3, 1987 Sedlmair
4648768 March 10, 1987 Hambric
4678470 July 7, 1987 Nashef et al.
4708377 November 24, 1987 Hunting
4711760 December 8, 1987 Blaushild
4717115 January 5, 1988 Schmitz
4793335 December 27, 1988 Frey et al.
4804290 February 14, 1989 Balsells
4812094 March 14, 1989 Grube
4858603 August 22, 1989 Clemow et al.
4904261 February 27, 1990 Dove et al.
4936851 June 26, 1990 Fox et al.
4950296 August 21, 1990 McIntyre
4955908 September 11, 1990 Frey et al.
4961740 October 9, 1990 Ray et al.
4976576 December 11, 1990 Mahaney
4978350 December 18, 1990 Wagenknecht
4994084 February 19, 1991 Brennan
5010783 April 30, 1991 Sparks et al.
5017069 May 21, 1991 Stencel
5020949 June 4, 1991 Davidson et al.
5026373 June 25, 1991 Ray et al.
5030220 July 9, 1991 Howland
5053049 October 1, 1991 Campbell
5062850 November 5, 1991 MacMillan et al.
5071437 December 10, 1991 Steffee
5084051 January 28, 1992 Törmälä et al.
5085660 February 4, 1992 Lin
5096150 March 17, 1992 Westwood
5108438 April 28, 1992 Stone et al.
5112354 May 12, 1992 Sires
5118235 June 2, 1992 Dill
5139424 August 18, 1992 Yli-Urpo
5147404 September 15, 1992 Downey
5180381 January 19, 1993 Aust et al.
5192327 March 9, 1993 Brantigan
5207543 May 4, 1993 Kirma
5211664 May 18, 1993 Tepic et al.
5235034 August 10, 1993 Bobsein et al.
5238342 August 24, 1993 Stencel
5275601 January 4, 1994 Gogolewski et al.
5281226 January 25, 1994 Davydov et al.
5284655 February 8, 1994 Bogdansky et al.
5290312 March 1, 1994 Kojimoto et al.
5298254 March 29, 1994 Prewett et al.
5304021 April 19, 1994 Oliver et al.
5314476 May 24, 1994 Prewett et al.
5314477 May 24, 1994 Marnay
5330535 July 19, 1994 Moser et al.
5348788 September 20, 1994 White
5368593 November 29, 1994 Stark
5380323 January 10, 1995 Howland
5385583 January 31, 1995 Cotrel
5397364 March 14, 1995 Kozak et al.
5405391 April 11, 1995 Hednerson et al.
5411348 May 2, 1995 Balsells
5423817 June 13, 1995 Lin
5425772 June 20, 1995 Brantigan
5439684 August 8, 1995 Prewett et al.
5458638 October 17, 1995 Kuslich et al.
5458641 October 17, 1995 Ramirez
5458643 October 17, 1995 Oka et al.
5478342 December 26, 1995 Kohrs
5487744 January 30, 1996 Howland
5489308 February 6, 1996 Kuslich et al.
5507818 April 16, 1996 McLaughlin
5514180 May 7, 1996 Heggeness et al.
5520690 May 28, 1996 Errico et al.
5522899 June 4, 1996 Michelson
5531746 July 2, 1996 Errico et al.
5534030 July 9, 1996 Navarro et al.
5534031 July 9, 1996 Matsuzaki et al.
5534032 July 9, 1996 Hodorek
5545842 August 13, 1996 Balsells
5549612 August 27, 1996 Yapp et al.
5549679 August 27, 1996 Kuslich
5554191 September 10, 1996 Lahille et al.
5556430 September 17, 1996 Gendler
5569308 October 29, 1996 Sottosanti
5570983 November 5, 1996 Hollander
5571190 November 5, 1996 Ulrich et al.
5571192 November 5, 1996 Schönhöffer
5578034 November 26, 1996 Estes
5593409 January 14, 1997 Michelson
5597278 January 28, 1997 Peterkort
5601553 February 11, 1997 Trebing et al.
5601554 February 11, 1997 Howland et al.
5607428 March 4, 1997 Lin
5607474 March 4, 1997 Athanasiou et al.
5609635 March 11, 1997 Michelson
5609636 March 11, 1997 Kohrs et al.
5609637 March 11, 1997 Biedermann et al.
5616144 April 1, 1997 Yapp et al.
5642960 July 1, 1997 Salice
5645606 July 8, 1997 Oehy et al.
5653708 August 5, 1997 Howland
5676666 October 14, 1997 Oxland
5676699 October 14, 1997 Gogolewski
5681311 October 28, 1997 Foley et al.
5683216 November 4, 1997 Erbes
5683394 November 4, 1997 Rinner
5683463 November 4, 1997 Godefroy et al.
5702449 December 30, 1997 McKay
5702451 December 30, 1997 Biedermann et al.
5702453 December 30, 1997 Rabbe et al.
5702455 December 30, 1997 Saggar
5713899 February 3, 1998 Marnay et al.
5713900 February 3, 1998 Benzel et al.
5725588 March 10, 1998 Errico et al.
5728159 March 17, 1998 Stroever et al.
5735853 April 7, 1998 Olerud
5735905 April 7, 1998 Parr
5755796 May 26, 1998 Ibo et al.
5766253 June 16, 1998 Brosnahan, III
5776194 July 7, 1998 Mikol et al.
5776196 July 7, 1998 Matsuzaki et al.
5776197 July 7, 1998 Rabbe et al.
5776198 July 7, 1998 Rabbe et al.
5776199 July 7, 1998 Michelson
5778804 July 14, 1998 Read
5782915 July 21, 1998 Stone
5785710 July 28, 1998 Michelson
5800433 September 1, 1998 Benzel et al.
5861041 January 19, 1999 Tienboon
5865845 February 2, 1999 Thalgott
5865849 February 2, 1999 Stone
5876402 March 2, 1999 Errico et al.
5876452 March 2, 1999 Athanasiou et al.
5879389 March 9, 1999 Koshino
5885299 March 23, 1999 Winslow et al.
5888222 March 30, 1999 Coates et al.
5888223 March 30, 1999 Bray, Jr.
5888224 March 30, 1999 Beckers et al.
5888227 March 30, 1999 Cottle
5895426 April 20, 1999 Scarborough et al.
5899939 May 4, 1999 Boyce et al.
5902303 May 11, 1999 Eckhof et al.
5902338 May 11, 1999 Stone
5904683 May 18, 1999 Pohndorf et al.
5904719 May 18, 1999 Errico et al.
5910315 June 8, 1999 Stevenson et al.
5911758 June 15, 1999 Oehy et al.
5920312 July 6, 1999 Wagner et al.
5922027 July 13, 1999 Stone
5931838 August 3, 1999 Vito
5944755 August 31, 1999 Stone
5951558 September 14, 1999 Fiz
5954722 September 21, 1999 Bono
5968098 October 19, 1999 Winslow
5972368 October 26, 1999 McKay
5976141 November 2, 1999 Haag et al.
5976187 November 2, 1999 Richelsoph
5980522 November 9, 1999 Koros et al.
5981828 November 9, 1999 Nelson et al.
5984967 November 16, 1999 Zdeblick et al.
5989289 November 23, 1999 Coates et al.
6013853 January 11, 2000 Athanasiou et al.
6017345 January 25, 2000 Richelsoph
6025538 February 15, 2000 Yaccarino, III
6033405 March 7, 2000 Winslow et al.
6033438 March 7, 2000 Bianchi et al.
6039762 March 21, 2000 McKay
6045579 April 4, 2000 Hochshuler et al.
6045580 April 4, 2000 Scarborough et al.
6056749 May 2, 2000 Kuslich
6066175 May 23, 2000 Henderson et al.
6080158 June 27, 2000 Lin
6080193 June 27, 2000 Hochshuler et al.
6086593 July 11, 2000 Bonutti
6086614 July 11, 2000 Mumme
6090998 July 18, 2000 Grooms et al.
6096080 August 1, 2000 Nicholson et al.
6096081 August 1, 2000 Grivas et al.
6099531 August 8, 2000 Bonutti
6110482 August 29, 2000 Khouri et al.
6113637 September 5, 2000 Gill et al.
6113638 September 5, 2000 Williams et al.
6120503 September 19, 2000 Michelson
6123731 September 26, 2000 Boyce et al.
6129763 October 10, 2000 Chauvin et al.
6136001 October 24, 2000 Michelson
6139550 October 31, 2000 Michelson
6143030 November 7, 2000 Schroder
6143033 November 7, 2000 Paul et al.
6156070 December 5, 2000 Incavo et al.
6193721 February 27, 2001 Michelson
6193756 February 27, 2001 Studer et al.
6193757 February 27, 2001 Foley et al.
6200347 March 13, 2001 Anderson et al.
6206922 March 27, 2001 Zdeblick et al.
6224602 May 1, 2001 Hayes
6231610 May 15, 2001 Geisler
6235033 May 22, 2001 Brace et al.
6235034 May 22, 2001 Bray
6235059 May 22, 2001 Benezech et al.
6241731 June 5, 2001 Fiz
6241769 June 5, 2001 Nicholson et al.
6245108 June 12, 2001 Biscup
6258089 July 10, 2001 Campbell et al.
6258125 July 10, 2001 Paul et al.
6261291 July 17, 2001 Talaber et al.
6261586 July 17, 2001 McKay
6264695 July 24, 2001 Stoy
6270528 August 7, 2001 McKay
6306139 October 23, 2001 Fuentes
6322562 November 27, 2001 Wolter
6331179 December 18, 2001 Freid et al.
6342074 January 29, 2002 Simpson
6364880 April 2, 2002 Michelson
6371986 April 16, 2002 Bagby
6371988 April 16, 2002 Pafford et al.
6371989 April 16, 2002 Chauvin et al.
6375681 April 23, 2002 Truscott
6383186 May 7, 2002 Michelson
6387130 May 14, 2002 Stone et al.
6395031 May 28, 2002 Foley et al.
6413259 July 2, 2002 Lyons et al.
6423063 July 23, 2002 Bonutti
6432106 August 13, 2002 Fraser
6447512 September 10, 2002 Landry et al.
6447546 September 10, 2002 Bramlet et al.
6454771 September 24, 2002 Michelson
6458158 October 1, 2002 Anderson et al.
6461359 October 8, 2002 Tribus et al.
6468311 October 22, 2002 Boyd et al.
6471724 October 29, 2002 Zdeblick et al.
6503250 January 7, 2003 Paul
6524312 February 25, 2003 Landry et al.
6558387 May 6, 2003 Errico et al.
6558423 May 6, 2003 Michelson
6558424 May 6, 2003 Thalgott
6562073 May 13, 2003 Foley
6569201 May 27, 2003 Moumene et al.
6575975 June 10, 2003 Brace et al.
6576017 June 10, 2003 Foley et al.
6579290 June 17, 2003 Hardcastle et al.
6592624 July 15, 2003 Fraser et al.
6602291 August 5, 2003 Ray et al.
6605090 August 12, 2003 Trieu et al.
6616671 September 9, 2003 Landry et al.
6620163 September 16, 2003 Michelson
6623486 September 23, 2003 Weaver et al.
6629998 October 7, 2003 Lin
6638310 October 28, 2003 Lin et al.
6645212 November 11, 2003 Goldhahn et al.
6652525 November 25, 2003 Assaker et al.
6656181 December 2, 2003 Dixon et al.
6679887 January 20, 2004 Nicholson et al.
6682561 January 27, 2004 Songer et al.
6682563 January 27, 2004 Scharf
6695846 February 24, 2004 Richelsoph et al.
6695851 February 24, 2004 Zdeblick et al.
6706067 March 16, 2004 Shimp et al.
6709456 March 23, 2004 Langberg et al.
6712818 March 30, 2004 Michelson
6730127 May 4, 2004 Michelson
6736850 May 18, 2004 Davis
6761739 July 13, 2004 Shepard
6770096 August 3, 2004 Bolger et al.
6786909 September 7, 2004 Dransfeld
6800092 October 5, 2004 Williams et al.
6805714 October 19, 2004 Sutcliffe
6808537 October 26, 2004 Michelson
6824564 November 30, 2004 Crozet
6833006 December 21, 2004 Foley et al.
6837905 January 4, 2005 Lieberman
6849093 February 1, 2005 Michelson
6855168 February 15, 2005 Crozet
6863673 March 8, 2005 Gerbec et al.
6872915 March 29, 2005 Koga et al.
6884242 April 26, 2005 LeHuec et al.
6890334 May 10, 2005 Brace et al.
6899735 May 31, 2005 Coates et al.
6902578 June 7, 2005 Anderson et al.
6916320 July 12, 2005 Michelson
6923756 August 2, 2005 Sudakov et al.
6953477 October 11, 2005 Berry
6962606 November 8, 2005 Michelson
6964664 November 15, 2005 Freid et al.
6964687 November 15, 2005 Bernard et al.
6972019 December 6, 2005 Michelson
6972035 December 6, 2005 Michelson
6974479 December 13, 2005 Trieu
6984234 January 10, 2006 Bray
7001385 February 21, 2006 Bonutti
7001432 February 21, 2006 Keller et al.
7018416 March 28, 2006 Hanson et al.
7033394 April 25, 2006 Michelson
7041135 May 9, 2006 Michelson
7044968 May 16, 2006 Yaccarino et al.
7044972 May 16, 2006 Mathys et al.
7060097 June 13, 2006 Fraser et al.
7066961 June 27, 2006 Michelson
7077864 July 18, 2006 Byrd, III et al.
7112222 September 26, 2006 Fraser et al.
7112223 September 26, 2006 Davis
7135024 November 14, 2006 Cook et al.
7135043 November 14, 2006 Nakahara et al.
7137984 November 21, 2006 Michelson
7147665 December 12, 2006 Bryan et al.
7163561 January 16, 2007 Michelson
7172627 February 6, 2007 Fiere et al.
7226452 June 5, 2007 Zubok
7226482 June 5, 2007 Messerli et al.
7232463 June 19, 2007 Falahee
7232464 June 19, 2007 Mathieu et al.
7238203 July 3, 2007 Bagga et al.
7255698 August 14, 2007 Michelson
7276082 October 2, 2007 Zdeblick et al.
7320708 January 22, 2008 Bernstein
7323011 January 29, 2008 Shepard et al.
7442209 October 28, 2008 Michelson
7491237 February 17, 2009 Randall et al.
7534265 May 19, 2009 Boyd et al.
7594932 September 29, 2009 Aferzon et al.
7601173 October 13, 2009 Messerli et al.
7608107 October 27, 2009 Michelson
7618456 November 17, 2009 Mathieu et al.
7625380 December 1, 2009 Drewry et al.
7637951 December 29, 2009 Michelson
7655042 February 2, 2010 Foley et al.
7704279 April 27, 2010 Moskowitz et al.
7846188 December 7, 2010 Moskowitz et al.
7846207 December 7, 2010 Lechmann et al.
7862616 January 4, 2011 Lechmann
7875076 January 25, 2011 Mathieu et al.
7942903 May 17, 2011 Moskowitz et al.
7993403 August 9, 2011 Foley et al.
8062303 November 22, 2011 Berry et al.
8128700 March 6, 2012 Delurio et al.
8182532 May 22, 2012 Anderson et al.
8211148 July 3, 2012 Zhang et al.
8273127 September 25, 2012 Jones et al.
8308804 November 13, 2012 Kureger
8328872 December 11, 2012 Duffield et al.
8343222 January 1, 2013 Cope
8353913 January 15, 2013 Moskowitz et al.
8382768 February 26, 2013 Berry et al.
8425607 April 23, 2013 Waugh et al.
8465546 June 18, 2013 Jodaitis et al.
8540774 September 24, 2013 Kueenzi et al.
8545567 October 1, 2013 Krueger
8641743 February 4, 2014 Michelson
8641768 February 4, 2014 Duffield et al.
8764831 July 1, 2014 Lechmann et al.
9005295 April 14, 2015 Kueenzi et al.
20010001129 May 10, 2001 McKay et al.
20010005796 June 28, 2001 Zdeblick et al.
20010010021 July 26, 2001 Boyd et al.
20010016777 August 23, 2001 Biscup
20010020186 September 6, 2001 Boyee et al.
20010031254 October 18, 2001 Bianchi et al.
20010039456 November 8, 2001 Boyer, II et al.
20010041941 November 15, 2001 Boyer, II et al.
20020004683 January 10, 2002 Michelson et al.
20020010511 January 24, 2002 Michelson
20020016595 February 7, 2002 Michelson
20020022843 February 21, 2002 Michelson
20020029084 March 7, 2002 Paul et al.
20020065517 May 30, 2002 Paul
20020082597 June 27, 2002 Fraser
20020082603 June 27, 2002 Dixon et al.
20020091447 July 11, 2002 Shimp et al.
20020095155 July 18, 2002 Michelson
20020099376 July 25, 2002 Michelson
20020099378 July 25, 2002 Michelson
20020106393 August 8, 2002 Bianchi et al.
20020111680 August 15, 2002 Michelson
20020128712 September 12, 2002 Michelson
20020128717 September 12, 2002 Alfaro et al.
20020147450 October 10, 2002 LeHuec et al.
20020169508 November 14, 2002 Songer et al.
20020193880 December 19, 2002 Fraser
20030045939 March 6, 2003 Casutt
20030078666 April 24, 2003 Michelson
20030078668 April 24, 2003 Michelson
20030125739 July 3, 2003 Bagga et al.
20030135277 July 17, 2003 Bryan et al.
20030153975 August 14, 2003 Byrd
20030167092 September 4, 2003 Foley
20030195626 October 16, 2003 Huppert
20030195632 October 16, 2003 Foley et al.
20030199983 October 23, 2003 Michelson
20040078078 April 22, 2004 Shepard
20040078081 April 22, 2004 Ferree
20040092929 May 13, 2004 Zindrick
20040093084 May 13, 2004 Michelson
20040102848 May 27, 2004 Michelson
20040126407 July 1, 2004 Falahee
20040133278 July 8, 2004 Marino et al.
20040143270 July 22, 2004 Zucherman et al.
20040176853 September 9, 2004 Sennett et al.
20040199254 October 7, 2004 Louis et al.
20040210219 October 21, 2004 Bray
20040210310 October 21, 2004 Trieu
20040210314 October 21, 2004 Michelson
20040249377 December 9, 2004 Kaes et al.
20040254644 December 16, 2004 Taylor
20050015149 January 20, 2005 Michelson
20050021143 January 27, 2005 Keller
20050033433 February 10, 2005 Michelson
20050049593 March 3, 2005 Duong et al.
20050049595 March 3, 2005 Suh et al.
20050065605 March 24, 2005 Jackson
20050065607 March 24, 2005 Gross
20050065608 March 24, 2005 Michelson
20050071008 March 31, 2005 Kirschman
20050085913 April 21, 2005 Fraser et al.
20050101960 May 12, 2005 Fiere et al.
20050149193 July 7, 2005 Zucherman et al.
20050154391 July 14, 2005 Doherty et al.
20050159813 July 21, 2005 Molz
20050159818 July 21, 2005 Blain
20050159819 July 21, 2005 McCormick et al.
20050171607 August 4, 2005 Michelson
20050177236 August 11, 2005 Mathieu et al.
20050240267 October 27, 2005 Randall et al.
20050240271 October 27, 2005 Zubock et al.
20050261767 November 24, 2005 Anderson et al.
20060020342 January 26, 2006 Ferree et al.
20060030851 February 9, 2006 Bray et al.
20060079901 April 13, 2006 Ryan et al.
20060079961 April 13, 2006 Michelson
20060085071 April 20, 2006 Lechmann et al.
20060089717 April 27, 2006 Krishna
20060129240 June 15, 2006 Lessar et al.
20060136063 June 22, 2006 Zeegers
20060142765 June 29, 2006 Dixon et al.
20060195189 August 31, 2006 Link et al.
20060206208 September 14, 2006 Michelson
20060229725 October 12, 2006 Lechmann et al.
20070088441 April 19, 2007 Duggal et al.
20070093819 April 26, 2007 Albert
20070106384 May 10, 2007 Bray et al.
20070118125 May 24, 2007 Orbay et al.
20070123987 May 31, 2007 Bernstein
20070162130 July 12, 2007 Rashbaum et al.
20070168032 July 19, 2007 Muhanna et al.
20070219635 September 20, 2007 Mathieu et al.
20070225806 September 27, 2007 Squires et al.
20070225812 September 27, 2007 Gill
20070250167 October 25, 2007 Bray et al.
20070270961 November 22, 2007 Ferguson
20080033440 February 7, 2008 Moskowitz et al.
20080051890 February 28, 2008 Waugh et al.
20080082169 April 3, 2008 Gittings
20080119933 May 22, 2008 Aebi et al.
20080133013 June 5, 2008 Duggal et al.
20080161925 July 3, 2008 Brittan et al.
20080177307 July 24, 2008 Moskowitz et al.
20080200984 August 21, 2008 Jodaitis et al.
20080249569 October 9, 2008 Waugh et al.
20080249575 October 9, 2008 Waugh et al.
20080249625 October 9, 2008 Waugh et al.
20080269806 October 30, 2008 Zhang et al.
20080275455 November 6, 2008 Berry et al.
20080306596 December 11, 2008 Jones et al.
20090076608 March 19, 2009 Gordon et al.
20090105830 April 23, 2009 Jones et al.
20090192613 July 30, 2009 Wing et al.
20090210062 August 20, 2009 Thalgott et al.
20090210064 August 20, 2009 Lechmann et al.
20090234455 September 17, 2009 Moskowitz et al.
20090326580 December 31, 2009 Anderson et al.
20100016901 January 21, 2010 Robinson
20100125334 May 20, 2010 Krueger
20100145459 June 10, 2010 McDonough et al.
20100145460 June 10, 2010 McDonough et al.
20110118843 May 19, 2011 Mathieu et al.
20110295371 December 1, 2011 Moskowitz et al.
20120101581 April 26, 2012 Mathieu et al.
20120109309 May 3, 2012 Mathieu et al.
20120109311 May 3, 2012 Mathieu et al.
20120109312 May 3, 2012 Mathieu et al.
20120109313 May 3, 2012 Mathieu et al.
20120179259 July 12, 2012 McDonough et al.
20130073046 March 21, 2013 Zaveloff et al.
20130073047 March 21, 2013 Laskowitz et al.
20130166032 June 27, 2013 McDonough et al.
20130268008 October 10, 2013 McDonough et al.
20140025168 January 23, 2014 Klimek et al.
20140121777 May 1, 2014 Rosen et al.
20140180422 June 26, 2014 Klimek et al.
20140257487 September 11, 2014 Lawson et al.
Foreign Patent Documents
2004/232317 November 2010 AU
2317791 August 1999 CA
2821678 November 1979 DE
30 42 003 July 1982 DE
39 33 459 April 1991 DE
42 42 889 June 1994 DE
44 09 392 September 1995 DE
4423257 January 1996 DE
195 04 867 February 1996 DE
l9504867 CI February 1996 DE
299 13 200 September 1999 DE
202004020209 May 2006 DE
0179695 April 1986 EP
0505634 September 1992 EP
0517030 December 1992 EP
0517030 April 1993 EP
0577178 January 1994 EP
0639351 February 1995 EP
0639351 March 1995 EP
504346 May 1995 EP
0517030 September 1996 EP
0505634 August 1997 EP
897697 February 1999 EP
0966930 December 1999 EP
0968692 January 2000 EP
0974319 January 2000 EP
1033941 September 2000 EP
1051133 November 2000 EP
1103236 May 2001 EP
0906065 January 2004 EP
1402836 March 2004 EP
1124512 September 2004 EP
1459711 July 2007 EP
1194087 August 2008 EP
2552659 April 1985 FR
2 697 996 May 1994 FR
2 700 947 August 1994 FR
2727003 May 1996 FR
2747034 October 1997 FR
2 753 368 March 1998 FR
157668 January 1921 GB
265592 August 1927 GB
2 148 122 May 1985 GB
2207607 February 1989 GB
2239482 July 1991 GB
2266246 October 1993 GB
3505416 November 1991 JP
9-280219 October 1997 JP
2006-513752 April 2006 JP
2229271 May 2004 RU
2244527 January 2005 RU
2307625 October 2007 RU
1465040 March 1989 SU
WO 88/03417 May 1988 WO
WO 88/10100 December 1988 WO
WO 90/00037 January 1990 WO
WO 92/01428 February 1992 WO
WO 92/06005 April 1992 WO
WO 95/21053 August 1995 WO
WO 96/39988 December 1996 WO
WO 97/20526 June 1997 WO
WO 97/23175 July 1997 WO
WO 97/25941 July 1997 WO
WO 97/25945 July 1997 WO
WO 97/39693 October 1997 WO
WO 98/17209 April 1998 WO
WO 98/55052 December 1998 WO
WO 98/56319 December 1998 WO
WO 98/56433 December 1998 WO
WO 99/009903 March 1999 WO
WO 99/09903 March 1999 WO
WO 99/27864 June 1999 WO
WO 99/29271 June 1999 WO
WO 99/32055 July 1999 WO
WO 99/38461 August 1999 WO
WO 99/38463 August 1999 WO
WO 99/56675 November 1999 WO
WO 99/63914 December 1999 WO
WO 00/07527 February 2000 WO
WO 00/07528 February 2000 WO
WO 00/25706 May 2000 WO
WO 00/30568 June 2000 WO
WO 00/40177 July 2000 WO
WO 00/41654 July 2000 WO
WO 00/59412 October 2000 WO
WO 00/66044 November 2000 WO
WO 00/66045 November 2000 WO
WO 00/74607 December 2000 WO
WO 01/08611 February 2001 WO
WO 01/56497 August 2001 WO
WO 01/62190 August 2001 WO
WO 01/80785 November 2001 WO
WO 01/56497 December 2001 WO
WO 01/93742 December 2001 WO
WO 01/95837 December 2001 WO
WO 01/56497 March 2002 WO
WO 01/93742 September 2002 WO
WO 2004/069106 August 2004 WO
WO 2005/007040 January 2005 WO
WO 2005/020861 March 2005 WO
WO 2006/138500 December 2006 WO
WO 2007/098288 August 2007 WO
2008/014258 January 2008 WO
WO 2008/082473 July 2008 WO
WO 2008/124355 October 2008 WO
WO 2008/154326 December 2008 WO
WO 2009/064644 May 2009 WO
WO 2010/054181 May 2010 WO
WO 2010/054208 May 2010 WO
WO 2012/088238 June 2012 WO
Other references
  • PCT: International Search Report & Written Opinion.
  • U.S. Appl. No. 11/199,599: Preliminary Amendment dated Jan. 9, 2008, 11 pages.
  • U.S. Appl. No. 11/199,599: Non-Final Office Action dated Apr. 1, 2009, 20 pages.
  • U.S. Appl. No. 11/199,599: Interview Summary including Draft Claim Amendments dated Sep. 24, 2009, 16 pages.
  • U.S. Appl. No. 11/199,599: Amendment dated Sep. 29, 2009, 30 pages.
  • U.S. Appl. No. 11/199,599: Final Office Action dated Dec. 24, 2009, 21 pages.
  • U.S. Appl. No. 11/199,599: Appeal Brief dated Apr. 15, 2010, 51 pages.
  • Chadwick et al., “Radiolucent Structural Materials for Medical Application”, www.mddionline.com/print/238, Jun. 2001, accessed Jul. 31, 2012, 9 pages.
  • “Jury Trial Demanded”, In The United States District Court for The District of Delaware, Case No. 1:11-cv-00652-LPSm filed Jul. 22, 2011, 8 pages.
  • Appendix 1 to Joint Claim Construction Brief; Synthes' Exhibits A-9, In The United States District Court for the District of Delaware Civil Action No. 1:11-cv-00652-LPS, Jun. 8, 2012, 192 pages.
  • Appendix 2 to Joint Claim Construction Brief; Globus' Exhibits A-F, In The United States District Court for the District of Delaware Civil Action No. 1:11-cv-00652-LPS, Jun. 8, 2012, 146 pages.
  • Appendix 3 to Joint Claim Construction Brief; Exhibits A-C, In The United States District Court for the District of Delaware Civil Action No. 1:11-cv-00652-LPS, Jun. 8, 2012, 38 pages.
  • Chadwick et al., “Radiolucent Structural Materials for Medical Applications,” www.mddionline.com/print/238, Jun. 1, 2001, accsessed date Jul. 31, 2012, 9 pages.
  • Expert Report of Dr. Domagoj Carie Regarding the Invalidity of U.S. Patent Nos. 7,846,207, 7,862,616 and 7,875,076, In The United States District Court for the District of Delaware, Civil Action No. 1:11-cv-00652-LPS, Nov. 5, 2012, 149 pages.
  • Expert Report of John F. Hall, M.D., United States District Court for the District of Delaware, Civil Action No. 1:11-cv-00652-LPS, Dec. 14, 2012, 27 pages.
  • Expert Report of Paul Ducheyne, Ph.D. Concerning Patent Validity, United States District Court District of Delaware, Civil Action No. 1:11-cv-00652-LPS, Dec. 13, 2012, 155 pages.
  • Expert Report of Richard J. Gering, Ph.D., CLP In The United States District Court for the District of Delaware, Civil Action No. 1:11-cv-00652-LPS, Dec. 14, 2012, 39 pages.
  • International Patent Application No. PCT/CH2003/00089, International Search Report dated Dec. 2, 2003, 3 pgs.
  • International Search Report, completed Aug. 16, 2007 for International Application No. PCT/US2007/005098, filed Feb. 27, 2007.
  • Joint Claim Construction Brief, In the United States District Court for the District of Delaware, Civil Action No. 1:11-cv-00652-LPS, Jun. 14, 2012, 97 pages.
  • Jonbergen et al., “Anterior Cervicallnterbody fusion with a titanium box cage: Early radiological assessment of fusion and subsidence”, The Spine Journal Jul. 5, 2005, 645-649.
  • Jury Verdict Form, United States District Court District of Delaware, Civil Action No. 1:11- cv-00652-LPS, Jun. 14, 2013, 20 pages.
  • Marcolongo et al., “Trends in Materials for Spine Surgery”, Biomaterials and Clinical Use, 6, 2011, 21 pages.
  • Memorandum Opinion, United States District Court District of Delaware, Civil Action No. 1:11-cv-00652-LPS, May 7, 2013, 33 pages.
  • Order, United States District Court District of Delaware, Civil Action No. 1:11-cv-00652-LPS, May 15, 2013, 4 pages.
  • Order, United States District Court District of Delaware, Civil Action No. 1:11-cv-00652-LPS, May 7, 2013, 7 pages.
  • Parlov et al., Anterior Lumbar Interbody Fusion with Threaded Fusion Cages and Autologous Grafts, Eur. Spine J., 2000, 9, 224-229.
  • Plaintiffs' Responses and Objections to Defendant Globus Medical, Inc.'s First Set of Interrogatories (Nos. 1-11), United States District Court for the District of Delaware, Civil Action No. 1:11-cv-00652-LPS, Nov. 14, 2011, 18 pages.
  • Plaintiffs' Supplemental Responses and Objections to Defendant Globus Medical Inc.'s Interrogatories Nos. 6-10 and Second Supplemental Responses and Objections to Interrogatory No. 5, United States District Court for the District of Delaware, Civil Action No. 11-cv-652-LPS, Sep. 1, 2012, 12 pages.
  • Redacted version of “Defendant Globus Medical, Inc.'s Answering Brief in Opposition to Plaintiff's Motion for Summary Judgment of No Anticipation by the Kozak and Michelson References”, Mar. 12, 2013, 233 pages.
  • Redacted version of “Opening Brief in Support of Plaintiffs' Motion for Summary Judgment of No Anticipation by the Kozak and Michelson References”, United States District Court District of Delaware, Civil Action No. 1:11-cv-00652-LPS, Feb. 13, 2013, 66 pages.
  • Redacted version of “Plaintiff's Reply Brief in Support of Plaintiff's Motion for Summary Judgment of No Anticipation by the Kozak and Michelson References”, Mar. 21, 2013, 11 pages.
  • Reply Report of Dr. Domagoj Carie Regarding the Invalidity of U.S. Patent Nos. 7,846,207, 7,862,616 and 7,875,076, In the United States District Court for the District of Delaware, Civil Action No. 1:11-cv-00652-LPS, Jan. 4, 2013, 81 pages.
  • Schleicher et al., “Biomechanical Comparison of Two Different Concepts for Stand alone anterior lumbar interbody fusion”, Eur. Spine J., Sep. 2008, 17, 1757-1765.
  • Scholz et al., “A New Stand-Alone Cervical Anterior Interbody Fusion Device”, Spine, Jan. 2009, 34(2), 6 pages.
  • Second Expert Report of Wilson C. Hayes, Ph.D., United States District Court for the District of Delaware, Civil Action No. 1:11-cv-00652-LPS, Dec. 14, 2012, 22 pages.
  • Spruit et al., The in Vitro Stabilising Effect of Polyether-etherketone Cages Versus a Titanium Cage of similar design for anterior lumbar interbody fusion, Eur. Spine J., Aug. 2005, 14 752-758.
  • Trial Transcript, United States District Court District of Delaware, Civil Action No. 1:11-cv-00652-LPS, Jun. 10, 2013, 114 pages.
  • Trial Transcript, United States District Court District of Delaware, Civil Action No. 1:11-cv-00652-LPS, Jun. 11, 2013, 98 pages.
  • Trial Transcript, United States District Court District of Delaware, Civil Action No. 1:11-cv-00652-LPS, Jun. 12, 2013, 75 pages.
  • Trial Transcript, United States District Court District of Delaware, Civil Action No. 1:11-cv-00652-LPS, Jun. 13, 2013, 94 pages.
  • Trial Transcript, United States District Court District of Delaware, Civil Action No. 1:11-cv-00652-LPS, Jun. 14, 2013, 26 pages.
  • Trial Transcript, United States District Court District of Delaware, Civil Action No. 1:11-cv-00652-LPS, Jun. 3, 2013, 98 pages.
  • Trial Transcript, United States District Court District of Delaware, Civil Action No. 1:11-cv-00652-LPS, Jun. 4, 2013, 110 pages.
  • Trial Transcript, United States District Court District of Delaware, Civil Action No. 1:11-cv-00652-LPS, Jun. 5, 2013, 99 pages.
  • Trial Transcript, United States District Court District of Delaware, Civil Action No. 1:11-cv-00652-LPS, Jun. 6, 2013, 80 pages.
  • Trial Transcript, United States District Court District of Delaware, Civil Action No. 1:11-cv-00652-LPS, Jun. 7, 2013, 97 pages.
  • Japanese Patent Application No. 2011-534926: Office Action dated Oct. 30, 2013, 7 pages.
  • Japanese Patent Application No. 2011-534928: Office Action dated Sep. 30, 2013, 11 pages.
  • Russian Patent Application No. 2011-1122797: Decision to Grant dated Oct. 9, 2013, 20 pages.
  • U.S. Appl. No. 60/988,661, filed Nov. 16, 2007, Kueenzi et al.
  • U.S. Appl. No. 61/535,726, filed Sep. 16, 2011, Zaveloff.
  • Synthes Spine, “SynFix-LR System. Instruments and Implants for Stand-Alone Anterior Lumbar Interbody Fusion (ALIF)”, Technique Guide dated 2008, pp. 2-40, Published by Synthes Spine (USA).
  • Synthes Spine, “Zero-P Instruments and Implants. Zero-Profile Anterior Cervical Interbody Fusion (ACIF) device”, Technique Guide dated 2008, pp. 2-32, Published by Synthes Spine (USA).
  • Bray, “InterPlate Spine Fusion Device: Subsidence Control Without Stress Shielding”, Orthopaedic Product News, Sep.-Oct. 2006, pp. 22-25.
  • International Search Report, Mailed Mar. 20, 2009, for PCT International Application No. PCT/US08/82473, filed Nov. 5, 2008.
  • Written Opinion, Mailed Mar. 20, 2009, for PCT International Application No. PCT/US08/82473, filed Nov. 5, 2008.
  • Synthes Spine, “CorticoCancellous ACF Spacer. An allograft space or anterior fusion of the cervical spine,” brochure, Masculoskeletal Transplant Foundationm, 2003, 6 pages.
  • International Patent Application PCT/US2011/066421, International Search Report dated Jun. 14, 2012, 31 pages.
Patent History
Patent number: 9192419
Type: Grant
Filed: Nov 6, 2009
Date of Patent: Nov 24, 2015
Patent Publication Number: 20100145459
Assignee: DePuy Synthes Products, Inc. (Raynham, MA)
Inventors: William P. McDonough (Collegeville, PA), William L. Strausbaugh (Newmanstown, PA), Christopher Bonner (Downingtown, PA), Thomas Pepe (Turnersville, NJ), Ralph Meili (Muttenz), Markus Hunziker (Aarau), Michael Jeger (Thuernen), Thomas Kueenzi (Downingtown, PA), David Koch (Bubendorf), Rainer Ponzer (Himmelried), Joern Richter (Kandern), Roger Berger (Bueren)
Primary Examiner: David Isabella
Assistant Examiner: Christine Nelson
Application Number: 12/613,866
Classifications
Current U.S. Class: Spine Bone (623/17.11)
International Classification: A61F 2/44 (20060101); A61B 17/88 (20060101); A61B 17/80 (20060101); A61F 2/46 (20060101); A61B 17/17 (20060101); A61B 17/86 (20060101); A61F 2/30 (20060101);